Saturday, October 22, 2016
- Mallinckrodt (NYSE:MNK) and Lannett Company (NYSEMKT:LCI) are tussling with the FDA over its withdrawal of previously approved abbreviated New Drug Applications (ANDAs) for generic versions of Janssen Pharmaceuticals' (NYSE:JNJ) CONCERTA (methylphenidate HCl) for the treatment of attention deficit hyperactivity disorder (ADHD).
- The agency pulled the approvals due to the lack of bioequivalence. Although bioequivalence was the basis for the original approvals, field reports of insufficient therapeutic effect surfaced after the products were launched. In an analysis of reports from the FDA's adverse event reporting system, FAERS, the reported therapeutic failures of the generics in question were almost 10x higher than Actavis' (NASDAQ:TEVA) generic version, the reference drug. Further analyses showed differences in the rates of drug release and absorption. Specifically, the companies' products delivered the active ingredient at a slower rate 7 - 12 hours after dosing.
- Lannett has requested a hearing with the FDA on the matter. Mallinckrodt will have to do the same after an appeals court removed its pending litigation with the agency from its oral argument calendar. It has filed a Motion to Reconsider in an attempt to be put back on the docket. Both firms insist that their generic versions are safe and effective.
- The FDA approves Merck's (NYSE:MRK) bezlotoxumab, branded as ZINPLAVA, to reduce the recurrence of Clostridium difficile (C. diff) infection (CDI) in adult patients who are receiving antibacterial treatment and are at high risk of CDI recurrence. ZINPLAVA should only be used in conjunction with antibacterial therapy since it is not indicated for the treatment of CDI.
- In June, the FDA's Advisory Committee voted 10-5 backing approval. Commercial launch will commence in Q1.
- Bezlotoxumab is a monoclonal antibody that specifically binds to C. diff toxin B, neutralizing its activity by preventing it from binding to host cells. Merck licensed it from Medarex in 2009.
- In a regulatory filing, Merit Medical Systems (NASDAQ:MMSI) discloses that it received a subpoena from the U.S. Department of Justice (DOJ) on October 19 requesting documents and other information related to certain of its marketing and promotional practices. It intends to cooperate fully with authorities.
- The company markets proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, mainly in cardiology, radiology and endoscopy.
Friday, October 21, 2016
- The FDA accepts for review Bristol-Myers Squibb's (BMY -0.7%) supplemental Biologics License Application (sBLA) seeking approval of Opdivo (nivolumab) for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma that has progressed on or after platinum-based chemotherapy, a Breakthrough Therapy indication. The agency's action date is March 2, 2017.
- The data supporting the filing was generated in the Phase 2 Checkmate-275 study which showed a 19.6% objective response rate in patients treated with Opdivo.
- Citing an "ideal time for a leadership change," Concordia International (CXRX +12.3%) CEO Mark Thompson plans to resign as soon as a successor is appointed. He will also step down as Chairman when a replacement is named.
- Something needs to change. Shares have lost 95% of their value over the past year.
- It is an area for only the most intrepid investors, but certain cannabis industry companies have experienced noteworthy runs this year, no doubt stoked by the continuing movement to legalize the recreational use of marijuana and the promise of cannabis-based consumer and medical products. California is the next state to vote on the use issue with Proposition 64 or the Adult Use of Marijuana Act. Residents will cast their votes on November 8.
- AeroGrow International (OTCQB:AERO) is up six-fold since January. It sells equipment used to grow "herbs and vegetables" indoors.
- United Cannabis (OTCQB:CNAB +25.5%) is also up about six-fold. It provides a range of consulting services supporting cannabis growers, including engineered facilities, security, regulatory compliance, genetics, cultivation, extraction methods, branding, retail operations, marketing and wholesale distribution.
- Cannabis Sativa (OTCQB:CBDS -10.4%) is up ~10-fold. Its goal is to brand and market ultra-high-quality cannabis products.
- Thinly traded nano cap Cerecor (CERC +16.7%) perks up on more than a 22x surge in volume, albeit on turnover of only 890K shares, as buyers spread the wealth stoked by Alkermes' (ALKS +33.5%) successful late-stage study of ALKS 5461 in major depressive disorder (MDD).
- Cerecor's lead product candidate is CERC-301, in Phase 2 development for the adjunctive treatment of MDD. Another mid-stage pipeline candidate for the same indication is CERC-501, a drug with a similar mechanism of action to ALKS 5461.
- Unsurprisingly, Alere (ALR +0.7%) stockholders voted overwhelmingly in favor of a merger with Abbott (ABT -1.1%) in a special meeting. Over 98% of the votes cast (representing 77% of the company's outstanding shares) backed the $56/share transaction. Yesterday's close was $44.10.
- The companies announced the deal in January but it became a bit wobbly when a rash of problems arose at Alere including dodgy billing practices, inappropriate revenue recognition and a government inquiry into its marketing and billing practices. The firms have agreed to engage a mediator to settle their differences.
- Read now: Merger Arbitrage - Alere And Abbott
- Nano cap Northwest Biotherapeutics (NWBO -17.3%) slumps on increased volume in response to its announcement that it has inked a deal with an institutional investor for the direct placement of up to 14M shares of common stock at $0.38, almost a 30% discount to yesterday's close of $0.5384. Closing date is October 26.
- Shares have lost over 96% of their value since July 2015.
- Alkermes (ALKS +31.6%) jumps out of the blocks on double normal volume this morning in response to its successful Phase 3 study, FORWARD-5, of ALKS 5461 in major depressive disorder (MDD).
- JPMorgan: believes ALKS 5461 approvable in U.S. based on FORWARD-5 results and totality of overall study data and could be worth $18/share in incremental value.
- Goldman Sachs: reintroduced ALKS 5461 into valuation model assuming peak sales at over $700M. Sees a chance that the FDA will request another Phase 3 study to confirm results (two earlier Phase 3s, FORWARD-3 and FORWARD-4, failed). ALKS price target raised to $48 (16% downside risk) from $35.
- Leerink: ALKS 5461 has "reasonable chance" of FDA approval. Price target raised to $70 (23% upside) from $57.
- Cowen & Co.: rates stock Outperform. Price target under review.
- The success of FORWARD-5 surprised many analysts since two other Phase 3's, FORWARD-3 and FORWARD-4, failed based on the same primary endpoint due to a higher-than-expected placebo effect. Enrollment was increased in FORWARD-5 to compensate.
- Previously: Alkermes +50%; announces positive topline results from 5461 depression drug (Oct. 20)
- Micro cap PTC Therapeutics (NASDAQ:PTCT) is up 4% premarket on light volume in response to its announcement that Roche (OTCQX:RHHBY) has initiated a Phase 2 clinical trial, SUNFISH, assessing RG7916 in pediatric and adult patients with Type 2/3 spinal muscular atrophy (SMA).
- The first part of the study will evaluate the safety and tolerability of escalating doses of RG7916 in ~36 subjects. After the optimal dose is selected, the study will move into a pivotal second stage to assess efficacy for up to 24 months followed by an open-label extension. The transition will trigger a $20M milestone to PTC from Roche.
- A trial in Type 1 SMA patients, FIREFISH, should commence in the coming months.
- SMA is an inherited disorder caused a deficiency in a protein called SMN which is coded by a gene called SMN1. A similar gene, SMN2, can code for SMN as well, but not as productively. RG7916 and RG7800 (an earlier SMA candidate) modify the splicing of the SMN2 gene to generate more SMN.
- Previously: PTC Therapeutics up 17% on licensee Roche's move into mid-stage study in spinal muscular dystrophy (Sept. 30)
- In an investor update yesterday, Moleculin Biotech (NASDAQ:MBRX) announced its "positive developments" for lead drug candidate Annamycin.
- Chairman & CEO Wally Kemp said that the company will be able to use the Annamycin inventory of licensee Dermin for its clinical trials thereby reducing its planned costs for its mid-stage studies over the next year.
- He adds that a more thorough review of a past investigator's clinical trial data revealed that administering Annamycin after fewer first-line attempts in myeloid leukemia patients may improve its efficacy and may allow an increase in the maximum tolerated dose (MTD) to up to 250 mg/m2 from 150 mg/m2. Dose-limiting toxicities (DLTs) have been observed at lower doses in earlier studies, specifically mucositis.
- The value proposition of Annamycin is efficacy comparable to doxorubicin without the cardiotoxicity.
- Investors appear unimpressed. Shares are down 12% premarket on light volume.
- Previously: Money flow ratchets up ahead of Moleculin Biotech's investor call today about leukemia candidate Annamycin; shares up 55% in two days (Oct. 20)
- Almost Family (NASDAQ:AFAM) upgraded to Outperform from Sector Perform with a $55 (31% upside) price target by RBC Capital.
- Walgreens Boots Alliance (NASDAQ:WBA) upgraded to Buy from Hold by Jefferies. Price target raised to $95 (17% upside) from $87.
- Arbutus Biopharma (NASDAQ:ABUS) upgraded to Neutral from Sell with a $3 price (0% upside) target by Chardan Capital.
- Quintiles IMS Holdings (NYSE:Q) downgraded to Hold from Buy with a $79 (6% upside) price target by Jefferies.
- Anthem (NYSE:ANTM) downgraded to Neutral from Overweight by JPMorgan. Price target lowered to $132 (6% upside) from $154.
- Bluebird bio (NASDAQ:BLUE) downgraded to Sell from Hold by Cantor Fitzgerald. Price target lowered to $37 (32% downside risk) from $42.
- Henry Schein (NASDAQ:HSIC) downgraded to Neutral from Buy by Baird. Price target lowered to $164 (7% upside) from $176.
- SCYNEXIS (NASDAQ:SCYX) initiated with Buy rating and $14 (272% upside) price target by H.C. Wainwright.
- Catalent (NYSE:CTLT) initiated with Overweight rating and $29 (19% upside) price target by KeyBanc.
- Coherus Biosciences (NASDAQ:CHRS) initiated with Outperform rating and $40 (32% upside) price target by Baird.
- Amarin (NASDAQ:AMRN) initiated with Buy rating and $5 (58% upside) price target by Citigroup.
- AC Immune (Pending:ACIU) initiated with Outperform rating and $18 (20% upside) price target by Credit Suisse.
- Sarepta Therapeutics (NASDAQ:SRPT) initiated with Outperform rating and $68 (39% upside) price target by Credit Suisse.
- Neurocrine Biosciences (NASDAQ:NBIX) initiated with Buy rating and $62 (36% upside) price target by Needham.
- AbbVie (NYSE:ABBV) initiated with Market Perform rating and $70 (13% upside) price target by Leerink Swann.
- Stryker (NYSE:SYK) initiated with Buy rating and $140 (22% upside) price target by SunTrust Robinson Humphrey.
- Newron Pharmaceuticals (OTC:NWPHF) announces that the FDA has accepted for review its resubmitted New Drug Application (NDA) seeking approval of Xadago (safinamide) as add-on therapy in both early and mid-to-late stage Parkinson's disease (PD) patients who are inadequately managed on their current therapy. The action date (PDUFA) is March 21, 2017. The company received a Complete Response Letter (CRL) on March 28 of this year regarding its original filing.
- Xadago was approved in Europe in February 2015.
- Safinamide is a new chemical entity, the first approved in Europe in 10 years for PD, with a unique mode of action including selective and reversible MAO-B (monoamine oxidase) inhibition, use-dependent Na (sodium) channels blockade and Ca (calcium) channels modulation which enables it to modulate abnormal glutamate release. Glutamate is an important neurotransmitter that plays a key role in neural activation.
- A Phase 3 clinical trial, KEYNOTE-045, assessing Merck's (NYSE:MRK) PD-1 inhibitor KEYTRUDA (pembrolizumab) in treatment-experienced patients with advance urothelial cancer has been stopped early after the independent Data Monitoring Committee determined that the study met its primary endpoint of overall survival (OS).
- KEYNOTE-045 is a 542-subject, randomized study evaluating KEYTRUDA as monotherapy compared to investigator choice chemotherapy (paclitaxel, docetaxel, vinflunine) in patients with metastatic or locally advanced/unresectable urothelial cancer that has progressed following platinum-based chemo. The co-primary endpoints are OS and progression-free survival (PFS). Secondary endpoints are overall response rate (ORR), duration of response (DOR) and safety. Participants were randomized to receive either 200 mg of KEYTRUDA every three weeks or investigator-choice chemo every three weeks.
- Detailed results will be submitted for presentation at a future medical conference.
- KEYTRUDA is Merck's fastest growing drug. It is currently approved for the treatment of melanoma, head and neck cancer and lung cancer. It is in clinical development for the treatment of more than 30 tumor types in more than 360 clinical trials.
Thursday, October 20, 2016
- Endo International plc (NASDAQ:ENDP) EVP and Chief Financial Officer Suketu Upadhyay notifies the company that he will resign effective November 22 to assume a senior finance position at another firm. EVP of Global Finance Operations Blaise Coleman will serve as interim CFO until a permanent successor is hired.
- Results from a Phase 3 clinical trial assessing Amgen's (NASDAQ:AMGN) XGEVA (denosumab) compared to zoledronic acid (ZA) for the prevention of bone complications in newly diagnosed multiple myeloma (MM) patients achieved its primary endpoint. Full results will be submitted for presentation at a future medical conference and for publication. The data will also be submitted to regulatory authorities.
- The primary endpoint was a non-inferiority test defined by the time to the first skeletal-related event (SRE).
- The secondary endpoints were not met. They were measures of superiority as defined by the time to the first-and-subsequent SRE and time to the first on-study SRE.
- Bone lesions frequently occur in MM patients which increase the risk of bone complications. Denosumab targets a particular ligand pathway called RANK to prevent the formation, function and survival of osteoclasts, a type of bone cell that absorbs bone tissue.
- XGEVA is approved in the U.S. to prevent serious bone problems in patients with bone metastases from solid tumors but is not approved to prevent bone problems in MM patients.
- Alkermes (NASDAQ:ALKS) announces positive topline results from FORWARD-5, the third phase 3 efficacy study to read out from the FORWARD pivotal program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder ("MDD") in patients with an inadequate response to standard antidepressant therapies.
- The study met its prespecified primary endpoint showing treatment with ALKS 5461 significantly reduced symptoms of depression in patients with MDD compared to placebo. ALKS 5461 was generally well tolerated.
- Management: “With the successful completion of the FORWARD-5 study and data from more than 1,500 patients to date, we have established a strong foundation of evidence of ALKS 5461’s clinical utility in the adjunctive treatment of major depressive disorder. With these data now in hand, we will move forward rapidly to meet with the FDA to determine the appropriate next steps toward a regulatory submission for ALKS 5461.”
- In the study, ALKS 5461 2mg/2mg met the prespecified primary endpoint of significantly reducing depression scores compared to placebo, as measured by 6-item Montgomery–Åsberg Depression Rating Scale (MADRS-6) scores (p=0.018). ALKS 5461 2mg/2mg also demonstrated statistically significant reductions in 10-item MADRS (MADRS-10) scores compared to placebo (p=0.026). The 1mg/1mg dose of ALKS 5461 showed improvement in depressive symptoms in the study, but did not separate significantly from placebo.
- ALKS +50% to $65 post-market.
- San Francisco, CA-based iRhythm Technologies (Pending:IRTC) shows that its timing is spot on in its first day of trading. Shares are up 56% from the $17 offer price on turnover of 5.5M. The IPO closing date is October 25.
- The original offering was 5.35M common shares at $13 - 15 but was increased to 6,294,118 shares at $17.
- Read now IPO Preview: iRhythm Technologies
- Thinly traded nano cap Moleculin Biotech (MBRX +41.3%) shows bullish action ahead of its conference call today to update investors on "positive developments" regarding lead product candidate Annamycin, its Phase 2-stage anthracycline candidate for the treatment of acute myeloid leukemia. Shares are up over 55% in two days so investors clearly expect to be impressed.
- Gilead Sciences (GILD +1.2%) announces positive results from four international Phase 3 clinical trials (POLARIS-1, -2, -3, -4) assessing its investigational once-daily, fixed-dose combination of sofosbuvir, velpatasvir and voxilaprevir (SOF/VEL/VOX) for the treatment of genotypes 1-6 chronic hepatitis C virus (HCV) infection. Complete results will be presented next month at The Liver Meeting in Boston.
- POLARIS-1, which enrolled 263 genotype 1-6 patients who had received prior treatment with an NS5A inhibitor, showed a cure rate (SVR12) of 96% (n=253/263) after 12 weeks of treatment with SOF/VEL/VOX.
- POLARIS-2, in direct-acting antiviral (DAA)-naive genotype 1-6 patients including some with cirrhosis, showed a cure rate of 95% (n=476/501) after eight weeks of treatment.
- POLARIS-3, in DAA-naive cirrhotic genotype 3 patients, showed a cure rate of 96% (n=106/110) after eight weeks of treatment.
- POLARIS-4, in DAA-experienced, NS5A-naive genotypes 1-4 patients, 46% with cirrhosis, showed a cure rate of 97% (n=177/182) after 12 weeks of treatment.
- Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor, velpatasvir is a pan-genotypic NS5A inhibitor and voxilaprevir is a pan-genotypic NS3/4A protease inhibitor.
- The company plans to file a New Drug Application (NDA) for Breakthrough Therapy-tagged SOF/VEL/VOX this quarter followed quickly by a marketing application in Europe.
- Micro cap Omeros (OMER +5.9%) perks up on 60% higher volume in response to its announcement of positive results from a Phase 2 clinical trial assessing lead product OMS721 for the treatment of patients who have thrombotic microangiopathy (TMA) associated with a hematopoietic stem cell transplant (HSCT), a condition with a high mortality rate. TMA means that there is damage to the smallest blood vessels and blood clots are involved.
- The data showed clinically meaningful improvements in measures of red blood cell destruction, specifically, lactate dehydrogenase (LDH) and haptoglobin levels, following treatment with OMS721 for up to eight weeks. In three patients who completed treatment, the average LDH level decreased as much as 43% from baseline (672 U/L to 380 U/L; p<0.01) and haptoglobin levels increased almost five-fold (1.54 g/L from 0.33 g/L; p<0.06). Both are biomarkers for hemolytic anemia. Mean platelet count increased as much as three-fold from baseline (57,000/uL from 18,000/uL).
- No significant safety signals were observed. According to ClinicalTrials.gov, the estimated study completion date is June 2018.
- OMS721 is the company's lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of thrombotic microangiopathies, including atypical hemolytic uremic syndrome (aHUS), a condition that was approved by the FDA for Alexion Pharma's (NASDAQ:ALXN) Soliris (eculizumab) in September 2011.
- An open-label Phase 2 clinical trial assessing Gilead Sciences' (GILD +0.2%) GS-4997 (selonsertib), alone or in combination with simtuzumab (SIM), for the treatment of patients with non-alcoholic steatohepatitis (NASH) with moderate-to-severe liver fibrosis (F2-F3) showed a positive treatment benefit. Top-line data will be presented at The Liver Meeting 2016 in Boston, November 11 - 15.
- In 67 evaluable patients treated with a once-daily dose of GS-4997 (18 mg or 6 mg), 43% (n=13/30) of those receiving 18 mg showed at least a one-stage improvement in liver fibrosis from baseline, with or without simtuzumab, while 30% (n=8/27) of those receiving 6 mg did so. Both beat the 20% (n=2/10) response rate observed with SIM alone. Based on the positive outcome, the company plans to proceed to Phase 3 development.
- Two other Phase 2 studies evaluating GS-4997, one in pulmonary arterial hypertension (PAH) and the other in diabetic kidney disease (DKD), failed to reach their primary endpoints so development for these indications will be terminated.
- GS-4997 inhibits an enzyme called apoptosis signal-regulating kinase 1 (ASK1) which plays a key role in oxidative stress-induced apoptosis (cell death). Oxidative stress is believed to play a key role in the development of NASH-related fibrosis.
- Simtuzumab is a humanized monoclonal antibody that inhibits (binds to) an enzyme called lysyl oxidase-like 2 (LOXL2) which plays a key role in forming blood vessels and connective tissue.
- The FDA accepts for review Teva Pharmaceutical Industries' (NASDAQ:TEVA) resubmitted New Drug Application (NDA) seeking approval of deutetrabenazine (SD-809) for the treatment of chorea (involuntary movements) associated with Huntington's disease, an Orphan Drug indication. The action date (PDUFA) is April 3, 2017.
- The company received a Complete Response Letter (CRL) in May regarding its original filing. The CRL citing the need to re-analyze blood levels of certain metabolites.
- SD-809 is an orally available small molecule inhibitor of vesicular monoamine 2 transporter (VMAT2) that is designed to regulate the levels of the neurotransporter dopamine in the brain.
- Previously: Teva receives CRL in response to SD-809 NDA (May 31)
- Nano cap SCYNEXIS (NASDAQ:SCYX) is ahead 10% premarket on light volume on the heels of a Buy recommendation and $14 (250% upside) price target from H.C. Wainwright.
- The company recently announced positive results from two mid-stage studies assessing lead product candidate SCY-078 for the treatment of vaginal yeast infection.
- Previously: SCYNEXIS' lead product candidate SCY-078 shows positive effect in two mid-stage studies; shares ahead 20% after hours (Oct. 5)
- Walgreens Boots Alliance (NASDAQ:WBA) fiscal Q4 results ($M): Net Sales: 28,636 (+0.4%); Retail Pharmacy USA: 20,747 (+4.0%); Retail Pharmacy Intl: 3,037 (-10.9%); Pharmaceutical Wholesale: 5,400 (-6.2%).
- Operating Income: 1,140 (+36.4%); Net Income: 1,035 (+999%); Non-GAAP Net Income: 1,166 (+20.3%); EPS: 0.95 (+999%); Non-GAAP EPS: 1.07 (+21.6%); CF Ops: 2,658 (+76.6%).
- Fiscal 2017 Guidance: Non-GAAP EPS: $4.85 - 5.20, including $0.05 - 0.12 accretion from Rite Aid.
- Shares are up 2% premarket on modest volume.
- Quest Diagnostics (DGX) Q3 results: Revenues: $1,885M (+0.3%); Operating Income: $322M (-49.0%); Net Income: $192M (-43.9%); EPS: $1.34 (-43.0%); Non-GAAP EPS: $1.37 (+7.0%); Quick Assets: $406M (+205.3%); CF Ops: $765M (+39.3%).
- 2016 Guidance: Revenue: ~$7.51B from $7.47B - 7.54B; GAAP EPS: $4.47 - 4.52 from $4.18 - 4.33; Non-GAAP EPS: $5.07 - 5.12 from $5.02 - 5.17; CF Ops: ~$1B from ~$880M; CAPEX: ~250M from $250M - 300M.
- Micro cap Rigel Pharmaceuticals (NASDAQ:RIGL) slumps 29% premarket on robust volume in response to its announcement of failed results in the second of two Phase 3 clinical trials assessing fostamatinib for the treatment of adult patients with chronic/persistent immune thrombocytopenia (low blood platelets).
- The trial, FIT 2 (Study 048), failed to achieve its primary endpoint of a statistically valid response rate compared to placebo. A responder was defined as one with a stable platelet response, specifically, a platelet count greater than 50,000/uL of blood on at least four of the last six scheduled clinic visits between weeks 14 and 24 of treatment. The response rate in the fostamatinib cohort was 18% (n=9/50) compared to 4% for placebo (n=1/24). The single responder in the placebo group caused the results to fall short of statistical significance (p=0.152).
- The first Phase 3, FIT 1 (Study 047) was successful. The response rate in the fostamatinib group was an identical 18% while the response rate for placebo was 0% (n=0/25). On a pooled basis, the data are statistically valid (response rate = 18% (n=18/101) vs. 2% (n=1/49) for placebo; p=0.007).
- An open-label extension study is recruiting patients. According to ClinicalTrials.gov, the estimated completion date is October 2017.
- Fostamatinib inhibits an enzyme called spleen tyrosine kinase (SYK) which plays a key role in certain blood cancers and autoimmune disorders.
- Management will host a conference call this morning at 8:00 am ET to discuss the data.
- Theravance (NASDAQ:TBPH) and development partner Mylan N.V. (NASDAQ:MYL) report successful results from two replicate Phase 3 clinical trials assessing revefenacin (TD-4208) for the treatment of chronic obstructive pulmonary disease (COPD). Both studies met their primary endpoint of a statistically valid improvement versus placebo in trough forced expiratory volume in one second (FEV1) after 12 weeks of treatment with each dose studied (88 mcg once daily and 175 mcg once daily).
- Both revefenacin doses were generally well-tolerated with comparable rates of adverse events (AEs) and serious adverse events to placebo. The most common AEs were exacerbations, cough, dyspnea (difficulty breathing) and headache.
- Complete results will be submitted for presentation at future scientific conferences.
- An ongoing Phase 3 safety study should be completed in 2017 followed by a New Drug Application (NDA) in the U.S. by year end.
- Revefenacin, a long-acting muscarinic antagonist (LAMA), is a once-daily nebulized bronchodilator.
- Theravance will host a conference call today at 8:00 am ET to discuss the results.
- England's National Institute for Health and Care Excellence (NICE), an advisory group to the National Health Service (NHS) on costs and quality, issues a positive final appraisal determination providing patient access to Celgene's (NASDAQ:CELG) OTEZLA (apremilast) for the treatment of chronic plaque psoriasis.
- Patients in England and Wales will now have access to OTEZLA, joining those in Scotland who have had access since June 2015.
- In a regulatory filing, DaVita (NYSE:DVA) discloses the financial details of its separation agreement with HealthCare Partners President Dennis Kogod, whose employment will be terminated on November 30.
- In exchanged for signing a release of the company and certain affiliates from claims, Mr. Kogod will receive a payment of $1.5M. In addition, the parties inked a three-year consulting agreement that will pay him $100K per month in addition to a lump sum payment of $1.8M in January 2017 and $100K at the conclusion of the agreement in 2019.
- Roche's (OTCQX:RHHBF) Q3 revenue climbed 4.5% to 12.48B Swiss francs ($12.6B) and almost hit forecasts of 12.55B francs, boosted by the strong performance of several of the company's cancer and immunotherapy treatments.
- These include Roche's trio of drugs for treating the HER2-positive form of breast cancer, Gazyva for chronic lymphocytic leukemia, Actemra for rheumatoid arthritis, and Esbriet for the lung disease idiopathic pulmonary fibrosis.
- The initial uptake of cancer immunotherapy Tecentriq has also been strong.
- Roche's overall pharmaceuticals sales rose to 9.68B francs from 9.34B, while diagnostics revenues grew to 2.8B francs from 2.6B francs.
- Roche reiterated that it expects FY sales to grow at a low- to mid-single-digit range at constant exchange rates and for core EPS to grow faster than revenues.
- Roche also confirmed that it expects to further increase its dividend in Swiss francs.
- Roche's shares are -0.5% in Zurich.
Wednesday, October 19, 2016
- Insulet (NASDAQ:PODD) announces that President & CEO Pat Sullivan has been elected to the additional role of Chairman. Other changes:
- Shacey Petrovic, President, Diabetes Products promoted to President & Chief Operating Officer.
- Director Dr. Jessica Hopfield appointed as Lead Independent Director.
- Dan Levangie, President, Drug Delivery will retire at year end.
- In a statement, UK-domiciled GW Pharmaceuticals (GWPH -2.7%) says it intends to withdraw its listing on the London Stock Exchange AIM effective at the close on December 2. It intends to maintain its Nasdaq listing under its current symbol. Holders of its American Depositary Receipts ((ADRs)) do not need to take any action.
- AIM is the LSE's international market for smaller growing companies. GW has been listed there since 2001.
- Under its Priority Review process, the FDA approves Eli Lilly's (LLY -0.2%) LARTRUVO (olaratumab), in combination with chemo agent doxorubicin, for the treatment of patients with advanced soft tissue sarcoma (STS) who cannot be cured with radiotherapy or surgery. STS occurs in ~12K Americans each year.
- Olaratumab is a monoclonal antibody designed to disrupt the platelet-derived growth factor receptor alpha (PDGF Receptor-alpha) pathway on tumor cells and on cells in the tumor microenvironment.
- The company's marketing application in Europe in currently under review after a positive Ad Comm vote a month ago.
- Read now Eli Lilly Could Be Turning The Corner
- Penny stock Cannabis Science (OTCPK:CBIS +31.6%) continues it torrid up move on a whopping 108M-share turnover. Shares have climbed almost four-fold in October. Today, the company announced that it is negotiating for two new drug development properties: a 200-acre parcel in California and a 100-acre site in Nevada. The additions would increase its total capacity to over 10M square feet.
- Cannabis develops medical products derived from one or more cannabinoid compounds.
- In its Investor Day yesterday, Kite Pharma (KITE -4%) provided an update on its preparedness for the U.S. launch of KTE-C19 and its development activities.
- It says it can produce KTE-C19, a CAR-T therapy for the treatment of certain blood cancers, in commercial quantities. Its manufacturing process is very efficient, with yields as high as 99%, and will be able to supply treatments for more than 4,000 patients a year with the ability to quickly expand. Next-generation automation will enter feasibility testing in 2017.
- Clinical trials are planned or are in process for six new blood cancer indications for KTE-C19.
- Four new Investigational New Drug (IND) applications are planned in the next two years: KITE-718 in non-small cell lung cancer and bladder cancer (2016); KITE-585 in multiple myeloma (2017) and KITE-796 in myeloid leukemia and KITE-439 in cervical cancer and head and neck cancer, both in 2018.
- Two replicate Phase 3 clinical trials assessing AbbVie's (ABBV +0.2%) Elagolix for the treatment premenopausal women with endometriosis showed statistically valid treatment effects in reducing menstrual pain (dysmenorrhea or DYS) and non-menstrual pelvic pain (NMPP). The data were presented at the 72nd American Society for Reproductive Medicine Scientific Congress & Expo in Salt Lake City, UT.
- In the two trials, both oral doses of Elagolix demonstrated a statistically improvement in the percentage of DYS and NMPP responders. In the first study, 46% of the subjects treated with 150 mg once daily and 76% of those treated with 200 mg twice daily were DYS responders, well above placebo's 20%. In terms of NMPP responders, the proportions were 50%, 55% and 36%, respectively. The second study showed similar results.
- The safety profile was consistent with earlier trials.
- Elagolix is an orally administered inhibitor of gonadotropin-releasing hormone receptors in the pituitary gland. It is being investigated in disorders mediated by sex hormones, such as uterine fibroids and endometriosis. AbbVie licensed it from Neurocrine Biosciences (NBIX -0.2%) in June 2010.
- AbbVie intends to file a New Drug Application (NDA) with the FDA in 2017.
- The first patient has been dosed in a Phase 2 clinical trial, LIMT HDV, assessing Eiger BioPharmaceuticals' (EIGR) pegylated interferon lambda 1a (lambda) for the potential treatment of chronic hepatitis delta (D) virus (HDV) infection. The 30-subject open-label study will evaluate the safety, tolerability and efficacy of two dose levels of lambda over 48 weeks of treatment. Participants will be randomized 1:1 to receive either 120 mcg or 180 mcg of lambda subcutaneously once/week for the duration of treatment followed by a 24-week observation period. Patients will also receive an anti-hepatitis B virus nucleoside/nucleotide analog throughout the treatment period. Enrollment is underway at the University of Auckland in New Zealand with additional sites planned in Israel and Pakistan.
- The company says it intends to explore lambda as monotherapy and in combination with SARASAR (lonafarnib), its lead HDV candidate (also in Phase 2 development).
- Lambda is a well-characterized type III interferon that stimulates immune responses. It targets type III interferon receptors which are different than the type 1 interferon receptors targeted by interferon alfa. Eiger secured global rights from Bristol-Myers Squibb (BMY) in April.
- HDV, a severe form of hepatitis in humans, occurs as a co-infection with HBV. It affects as many as 20M people worldwide.
- Despite being sued by St. Jude Medical (NYSE:STJ) alleging "false statements, false advertising, conspiracy and manipulation of the financial markets" related to the security of its implanted devices, short seller Muddy Waters fans the flames with a new video that reportedly shows how to reverse engineer the company's Merlin equipment allowing a hacker to manipulate certain commands which could turn the implanted cardiac device off completely or deliver an unnecessary shock to the heart.
- Predictably, St. Jude says it stands behind the security and safety of its devices and criticizes Muddy for its "irresponsible release of information that is intended for financial gain." Nevertheless, it has created a cybersecurity medical advisory board and will continue to work with researchers to ensure that it has a thorough understanding of the cyber risks and potential vulnerabilities related to its products.
- The company is in the midst of being acquired by Abbott (NYSE:ABT) for $25B.
- Shares are down 2% premarket on increased volume.
- Puma Biotechnology (NYSE:PBYI) eases 6% premarket on light volume ahead of the specifics from the company's $150M equity offering announced after the close yesterday. Details should be forthcoming.
- Nano cap Cerulean (NASDAQ:CERU) rockets 78% premarket on the heels of two positive developments.
- First, it has entered into a $20M stock purchase agreement with Aspire Capital Fund, LLC under which Aspire bought 800K shares of common stock at $1.25, up almost 84% from yesterday's close of $0.6808. Cerulean has the right to sell up to the remaining $19M to Aspire over a 24-month period based on a formula linked to then-current market prices. It has also issued 700K commitment shares to Aspire. No warrants are involved.
- Second, Cerulean has entered into a strategic collaboration with Novartis (NYSE:NVS) to develop nanoparticle-drug conjugate (NDC) product candidates for up to five targets. Cerulean will leverage its proprietary Dynamic Tumor Targeting technology with Novartis' proprietary compounds. It will be responsible for creating the NDC candidates while Novartis will be responsible for further development and commercialization.
- Under the terms of the agreement, Cerulean will receive an upfront payment of $5M plus funding for five full-time equivalents (e.g., five full-time employees or 10 employees working half time). It will also be eligible for milestones and single-digit-to-low-double-digit royalties on net sales.
- Abbott (NYSE:ABT) Q3 results ($M): Total Revenues: 5,302 (+3.0%); Nutrition: 1,755 (-1.9%); Diagnostics: 1,213 (+4.9%); Est. Pharmaceuticals: 1,012 (+5.3%); Medical Devices: 1,310 (+6.5%).
- Net Income: (329) (-156.7%); EPS: (0.22) (-157.9%); Non-GAAP EPS: 0.59 (+9.3%).
- Top Performers: Diabetes Care International: 210 (+18.6%); Total Diabetes Care: 306 (+11.3%); Vascular U.S.: 305 (+9.7%); POC International: 24 (+9.1%).
- Laggards: Molecular U.S.: 42 (-10.6%); Pediatric Nutrition International: 553 (-9.2%); Total Pediatric Nutrition: 967 (-3.9%).
- 2016 Guidance: EPS: $0.59 - 0.61 from $1.26 - 1.36; Non-GAAP EPS: $2.19 - 2.21 from $2.14 - 2.24.
- Shares are down 1% premarket on light volume.
- St. Jude Medical (STJ +2.3%) Q3 results: Revenues: $1,499M (+11.9%); Total U.S. Sales: $783M (+11.1%); Total International Sales: $716M (+12.9%); Operating Income: $286M (-2.7%); Net Income: $212M (-1.4%); EPS: $0.73 (-2.7%); Non-GAAP EPS: $0.99 (+2.1%); Quick Assets: $394M (-40.9%).
- Q4 and FY16 Guidance: Due to the planned merger with Abbott, St. Jude Medical is withdrawing financial guidance for the fiscal year 2016.
- Results from a Phase 2 clinical trial showed patients with cocaine use disorder (CUD) who were treated with Omeros' (NASDAQ:OMER) OMS405 experienced a significant time-dependent reduction is cocaine craving compared to placebo. The study was performed at the Center for Neurobehavioral Research on Addition, University of Texas Health Science Center in Houston.
- The trial randomized 30 participants to receive either OMS405 or placebo daily for 12 weeks. Measures of impulsivity, decision-making and cocaine craving were recorded at multiple time points. A subgroup of 19 (9 - OMS405 and 10 -placebo) underwent brain scans to measure white matter integrity before and after treatment.
- In addition to the reduction in cocaine craving in the test group, treated patients also showed improvement in white matter integrity in four targeted regions of interest. There are no currently available drugs to treat cocaine addiction.
- The data were recently presented at the 2016 College on Problems of Drug Dependence meeting in Palm Springs, CA. The findings has also been submitted for publication.
- OMS450 is a peroxisome proliferator-activated receptor (PPAR)-gamma agonist. It is also a target for drugs that treat diabetes and atherosclerosis.
- OMER is up 8% premarket on light volume.
- A Phase 3 clinical trial assessing Merck's (NYSE:MRK) letermovir (MK-8228) for preventing clinically significant cytomegalovirus (CMV) infection in CMV-seropositive adults who have undergone an allogeneic hematopoietic stem cell transplant (HSCT) met its primary endpoint of a statistically valid percentage of patients with clinically significant CMV infection up to 24 weeks after HSCT. Full results will be submitted for presentation at a future scientific conference.
- The study enrolled 540 subjects who received letermovir once daily either in an oral tablet or intravenously. Therapy was begun as early as the same day as the HSCT and no later than 28 days post-transplant and continued for ~100 days.
- Letermovir is a 3,4 dihydro-quinazoline which is a new class of non-nucleoside CMV inhibitors. It inhibits viral replication by targeting the viral terminase complex. It has Orphan Drug status in the U.S., Europe and Japan and Fast Track status in the U.S.
- Merck acquired global rights to letermovir in 2012 in a deal with AiCuris GmbH & Co. KG.
- In a surprising development, CRISPR Therapeutics (Pending:CRSP) downsizes its IPO to 4M common shares from 4.7M and drops the price to $14, below the original range of $15 - 17. Underwriters over-allotment is an additional 600K shares. Closing date is October 24. Trading begins today.
- The company was co-founded by one of the CRISPR/Cas9 discoverers, Emmanuelle Charpentier. The technology is the "next big thing" in biotech. Investors will want to keep an eye on this one, along with Editas Medicine (NASDAQ:EDIT) and Intellia Therapeutics (NASDAQ:NTLA).
- Nektar Therapeutics (NASDAQ:NKTR) eases 3% premarket on average volume in response to the pricing of its public offering of 13M shares of common stock at $13.50. Underwriters over-allotment is an additional 1.95M shares. Net proceeds will fund R&D, working capital and general corporate purposes.
- Yesterday's close was $14.08.
- Ascendis Pharma A/S (NASDAQ:ASND) prices its public offering of 6,315,789 American Depositary Shares (ADSs) at $19. Each ADS equals one ordinary share. Underwriters over-allotment is an additional 947,368 ADSs. Closing date is October 24.
- Net proceeds of ~$120M will fund the clinical development and regulatory approval of TransCon Growth Hormone, the development of other product candidates, working capital and general corporate purposes.
- Yesterday's close was $20.09.
- Natus Medical (BABY) Q3 results: Revenues: $90.9M (-3.9%); Operating Income: $15.2M (-5.6%); Net Income: $13.2M (+21.1%); EPS: $0.40 (+21.2%); Non-GAAP EPS: $0.39 (unch); Quick Assets: $106.5M (+10.6%); CF Ops: $35.5M (+130.5%).
- Q4 Guidance: Revenue: $107M - 109M; GAAP EPS: $0.46 - 0.49; Non-GAAP EPS: $0.52 - 0.55.
- 2016 Guidance: Revenue: $381.2M - 383.2M; GAAP EPS: $1.43 - 1.46; Non-GAAP EPS: $1.63 - 1.66.
- Blackstone (NYSE:BX) is the lead bidder to acquire physician-services company Team Health (NYSE:TMH), Reuters reports.
- The agency couldn't say what Blackstone has offered, although Team Health closed +7.2% at $40.25 yesterday, giving it a market cap of $2.93B.
- Blackstone has already owned Team Health before - from 2005-2009 - and its second pursuit of the company comes amid consolidation in the sector.
- Earlier this year, Team Health was forced to make board changes following pressure from activist investors such as Jana Partners.
Tuesday, October 18, 2016
- The FDA's Bone, Reproductive and Urologic Drugs Advisory Committee will meet tomorrow to discuss privately held Serenity Pharmaceuticals' New Drug Application (NDA) seeking approval of desmopressin nasal spray for the treatment of adult onset nocturia (waking up during the night at least twice to pass urine).
- FDA briefing doc
- Errata to FDA briefing doc
- Serenity briefing doc
- Update: The committee voted 14-4 that the benefits of desmopressin nasal spray outweigh the risks and 17-1 that there is substantial evidence to conclude that at least one of the doses is effective.
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