Today - Friday, August 22, 2014
- The DEA has reclassified hydrocodone combination drugs to stem a rise in their abuse, and will now label them in a category reserved for medical substances with the highest potential for harm.
- The move has been resisted by many drug makers and wholesalers, but others like Mallinckrodt (NYSE:MNK) support it and say it will have no significant impact on their business.
- Major makers of hydrocodone combination drugs include Actavis (NYSE:ACT), Teva (NYSE:TEVA) and AbbVie (NYSE:ABBV).
- Allergan's (NYSE:AGN) request to advance its lawsuit against Valeant Pharmaceuticals (NYSE:VRX) and Pershing Square has been denied by a California federal judge.
- Allergan claims the two engaged in insider trading ahead of their takeover bid, saying their unusual partnership violated securities regulations.
- Pershing Square's Bill Ackman began acquiring a stake in Allergan in February in partnership with Valeant after the two had begun discussing offering a bid for the company. Ackman only disclosed his ~10% stake the day before they made the offer.
- Previously:The rhubarb continues as Allergan pursuers file countersuit
Thursday, August 21, 2014
- In a regulatory filing, Isis Pharmaceuticals (ISIS -3.1%) discloses that it earned an $18M milestone payment from development partner Biogen Idec (BIIB -1.1%) by virtue of dosing the first infant in the ENDEAR Phase 3 clinical trial evaluating ISIS-SMNrx as a treatment for spinal muscular dystrophy.
- Ampliphi Biosciences (OTCQB:APHB +11.4%) restates its financial statements for the quarters ended September 30, 2013, December 31, 2013 and March 31, 2014 and for the year ended December 31, 3013 due to non-cash adjustments related to its Series B Preferred Stock dividend clause to reflect its treatment as a compound derivative.
- It will restate its financials for the year ended December 31, 2013 due to a reclassification of in-process R&D related to its acquisition of Biocontrol Ltd.
- The financials for the years ended December 31, 2011, 2012 and 2013 will be revised to recognize amortization of certain patents.
- The FDA clears Eliquis (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the reduction in the risk of recurrent DVT and PE following initial therapy.
- This expands its label beyond its initial indication as a treatment to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
- In 2007, Bristol-Myers Squibb (BMY) and Pfizer (PFE -0.3%) entered into a global collaboration to develop and commercialize apixaban, an oral anticoagulant discovered by BMY.
- Shares of thinly-traded nano cap Heat Biologics (HTBX +34.3%) jump on a 10x surge in volume (~1.1M) on no news.
- Shares have languished since last July's IPO at $10. Prices peaked at $15.29 on October 3 and bottomed at $3.60 on August 7.
- The company's lead product candidate is the cancer immunotherapeutic HS-110 (viagenpumatucel-L) for non-small cell lung cancer.
- Health Canada approves the incorporation of next generation MRI core technology into Imris' (IMRS) Visius Surgical Theatre. The technology is based on the Siemens Aera 1.5T and Skyra 3.0T MRI scanners. It enables better image quality, faster 3D image acquisition and improved ease-of-use and workflow during surgical procedures using intraoperative MRI.
- The FDA cleared the advancements in February 2014 and the EC cleared them last month.
- The FDA clears Intuitive Surgical's (ISRG +1%) Firefly Fluorescence Imaging feature that is used with the da Vinci Si System. Previously an option, Firefly will now ship automatically with all new systems.
- The feature enables real time visual assessment of vessels, blood flow and related tissue perfusion in addition to the assessment of major ducts that connect to the gallbladder.
- Some observers believe Pfizer (PFE -0.4%) will rekindle its bid for AstraZeneca (AZN +3%) by late 2014. The British firm rejected its ₤71B offer in May. Pfizer walked away despite being within 7% of the price AstraZeneca wanted.
- Under British takeover rules, the negotiations could restart as early as August 26 if AstraZeneca invites Pfizer back to the table. Pfizer cannot initiate discussions until November 26. The rules also allow Pfizer to make a single offer via private phone call to AstraZeneca but this option is rarely used because the process stops if the target says no.
- It all depends on Ian Read's enthusiasm for a higher bid. This may be unlikely considering what happened in May.
- Eli Lilly (LLY +0.5%) Bio-Medicines chief David Ricks says that "complete resolution of psoriasis is possible for significantly more people" after the company's therapy candidate, ixekizumab, achieves all primary and secondary endpoints in a 3,866-patient Phase 3 clinical trial comparing it to placebo and Amgen's (AMGN -0.1%) Enbrel (etanercept).
- Patients receiving both dosing regimens of ixekizumab (80 mg every two or four weeks) had significantly greater levels of skin clearance than the control group or the etanercept cohort. Between 78% and 90% of the test group achieved at least a 75% reduction in PASI score at 12 weeks. Also, 31% to 41% achieved PASI 100 (clear skin) at week 12 compared to 5% - 7% in the etanercept group.
- Lilly plans to submit its marketing application to regulators in 1H 2015.
- Sarepta Therapeutics (SRPT) establishes a multi-year multi-product partnership with Colorado-based Flagship Biosciences LLC to develop automated tissue-based quantitative tests related to muscular dystrophy that will support the advancement of Sarepta's product pipeline.
- There is a significant need for the ability to quantify dystrophin levels, for example, since the absence of the protein causes Duchenne muscular dystrophy. Measuring the specific levels of the biomarker in biopsy samples would be the most effective way to assess a therapy's (eteplirsen) efficacy.
- Financial details of the partnership are not disclosed.
- In a 138-patient Phase 3 clinical trial evaluating the safety and efficacy of Baxter International's (BAX +0.9%) BAX 855, an extended half-life recombinant factor VIII (rFVIII) for the treatment of hemophilia A, the product candidate met its primary endpoint of reducing annualized bleed rates (ABR) in the prophylaxis arm versus the on-demand arm.
- Patients in the twice-weekly prophylaxis arm experienced a 95% reduction in median ABR compared to the on-demand group (1.9 vs. 41.5, respectively). BAX 855 was also effective in treating bleeding episodes considering that 96% were controlled with one or two infusions.
- The half life of BAX 855 was 1.4x - 1.5x that of Advate [antihemophilic factor (recombinant)].
- The company expects to submit its BLA for BAX 855 before the end of 2014.
- Auxilium Pharmaceuticals (NASDAQ:AUXL) announces the results from a Phase 2a clinical trial evaluating the safety and efficacy of injections of collagenase clostridium histolyticum (CCH) for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Three doses (low-0.06mg; mid-0.48mg; high-0.84mg) of CCH showed an improvement in the appearance of cellulite as measured by investigator- and patient-generated scores on the Global Aesthetic Improvement Scale (GAIS).
- The mid and high dose groups demonstrated a statistically significant improvement in the appearance of cellulite (measured by GAIS scores) with a p-value of <0.05. In these two groups, 68% of patients rated themselves "satisfied" or "very satisfied" with the results compared to 34% in the placebo cohort.
- Dulling the veneer of the results is the fact that the trial is based on subjective observational data, as evidenced by the 34% satisfied/very satisfied proportion of the control group. The results would be more robust if the reduction in cellulite was independently quantified. Also, the p-value, ideally, would be <0.01 or less.
- Ampio Pharmaceuticals (NYSEMKT:AMPE) issues a press release stating that the data analysis from its just-completed Phase 3 STEP trial (STEP) evaluating single injection Ampion (human serum albumin) versus placebo as a treatment for osteoarthritis of the knee may be delayed due to the discovery that the study drug may have been exposed to lower temperatures during shipping than permitted by its specifications despite the fact that the products were packaged correctly and shipped by a specialized drug shipment vendor. Since exposure to low temps has the potential to compromise the potency of Ampion, the firm questions whether it should use the data in its BLA submission. The company has apparently contacted the FDA for guidance on the issue.
- Coincidentally, Ampio just happens to have a solution to the problem. It has 6-week interim data from its ongoing Phase 3 trial evaluating three injections of Ampion for osteoarthritis of the knee. Patients improved 86% on pain score and 87% on function score. Its August 18 press release refers to the data as "very positive" results.
- The company says that it is meeting with its regulatory advisors about the feasibility of substituting the multi-injection data for the singe-injection data in its BLA submission.
- AMPE share are down 19% premarket on robust volume.
- Ilumina (NASDAQ:ILMN) has formed collaborative partnerships with AstraZeneca (NYSE:AZN), Janssen Biotech (NYSE:JNJ) and Sanofi (NYSE:SNY) to develop a universal next-generation sequencing (NGS) system focused on oncology. The system will employ an multi-gene panel that will be used for patient selection in clinical trials of targeted cancer therapies. Illumina plans to commercialize the tests after obtaining regulatory approval.
- The emergence of panel-based assays will be a paradigm shift from today's single-analyte companion diagnostics.
- An estimated 800 oncology drugs are in development worldwide. At present, 125 cancer driver genes, 71 tumor suppressors and 54 oncogenes that drive tumor growth through 12 cellular signalling pathways have been discovered.
- The USPTO issues a Notice of Allowance to BioLineRx (NASDAQ:BLRX) covering the use of its polymer, BL-7010, for the prevention or decreasing of gluten's deleterious side effects on the gastrointestinal mucosa. The patent, when issued, will be in effect until 2026.
- BL-7010 is a non-absorbable orally available polymer intended for the treatment of celiac disease. It has a high affinity for gliadins, the immunogenic proteins in gluten that cause celiac disease. BL-7010 masks gliadins from enzymatic degradation which prevents the formation of immunogenic peptides that trigger the immune response. The immune response to gluten is thereby significantly reduced. BL-7010 is excreted via the bowel and not absorbed into the blood stream.
- Galena Biopharma's (NASDAQ:GALE) BOD fired CEO Mark Ahn on Monday according to TheStreet's Adam Feuerstein. Its action followed an internal investigation into the controversial stock promotion campaign where Galena's IR firm hired writers who used false names to submit bullish articles on investor web sites like Seeking Alpha.
- Galena is currently dealing with an SEC investigation into the matter as well as various lawsuits in federal and district court.
- Shares closed yesterday at $2.32, down 70% from January 14's peak of $7.77.
- Patterson Companies (NASDAQ:PDCO) fiscal Q1 results: Revenues: $1,059.5M (+20.4%); Gross Profit: $296.2M (+5.2%); Operating Expenses: $211.5M (+5.6%); Operating Income: $84.8M (+4.3%); Net Income: $50.3M (+9.6%); EPS: $0.50 (+11.1%); Quick Assets: $302.3M (-1.1%); CF Ops: $68.8M (+224.5%).
- Fiscal 2015 Guidance: EPS: $2.20 - 2.30.