Today - Tuesday, April 21, 2015
- SA author Jeff Eiseman says shares could be worth anywhere from $54 to $225, and thinks other (bullish) analysts aren't bullish enough.
- Source: Tonix Pharmaceuticals: Four Data-Based Valuations Of A Deeply Underappreciated Pharmaceutical Company
- 50% stock and 50% cash
- The proposal gives Mylan (NASDAQ:MYL) shareholders a 37.7% premium to the stock price of Mylan on April 7, 2015, the last day of trading prior to Mylan's press release regarding its unsolicited proposal for Perrigo (NYSE:PRGO), and a 48.3% premium to the unaffected stock price of Mylan on March 10, 2015, which is the last day of trading prior to widespread speculation of a transaction between Teva (NYSE:TEVA) and Mylan.
- Expected to be significantly accretive to Teva non-GAAP EPS, starting in the mid-teens in year 1 and approaching 30% by year 3.
- Teva/Mylan product offerings would create a combined pipeline of over 400 pending ANDAs and over 80 first-to-files in the U.S.
- MYL +9.3% premarket to $74.40. TEVA +2.8% premarket.
- Source: Press Release
- Previously: Bloomberg: Teva offer for Mylan could come today (Apr. 21)
- Previously: Mylan says rumored Teva marriage would not makes sense (Apr. 20)
- Related: Why Does Mylan Want To Buy Perrigo? (Apr. 9)
8:47 AMAlnylam's patisiran shows promise of halting neuropathy progression in patients with genetic disorder
- At the 67th Annual Meeting of the American Academy of Neurology, Alnylam (NASDAQ:ALNY) presented 12-month clinical data from its ongoing Phase 2 open-label extension study of its RNAi therapeutic, patisiran, in development for the treatment of transthyretin-mediated amyloidosis in patients with familial amyloidotic polyneuropathy (FAP), a genetic disorder characterized by abnormal deposits of the protein amyloid in the body's tissues and organs. It is caused by mutations in the TTR gene, which provides instructions for producing transthyretin (TTR).
- The results showed a mean 2.5-point decrease in modified Neuropathy Impairment Score at 12 months in patients who had reached the 12-month endpoint (n=20) at the time of data cutoff. This compares favorably with the 13 - 18-point increase cited in the literature in untreated FAP patients with similar baseline characteristics. Patients treated with patisiran achieved a sustained mean serum TTR knockdown at the 80% target level for ~16 months, with up to an 88% mean knockdown between doses. Researchers believe that TTR knockdown has the potential to halt neuropathy progression in FAP patients.
- 18-month data should be available later this year. The company will host a conference call this morning at 9:00 am ET to discuss the results.
- Shares are up 9% premarket on light volume.
- Traders in nano cap Novogen (NASDAQ:NVGN) appear to be taking money off the table this morning. Shares are down 25% premarket on robust volume. This is not surprising considering the stock's 6x up move since mid-December.
- No doubt adding to the selling is the company's announcement of a private placement of 51M ordinary shares, each with one six-month option to purchase one ordinary share at AU$0.30 and one-half of a five-year option to purchase one ordinary share at AU$0.40, to U.S. institutional investors. Existing shareholders will be offered a one-for-six non-renounceable rights issue of fully-paid ordinary shares that includes the same two options at no charge.
- The company expects to raise as much as AU$30.5M via the issuance of up to ~98.7M ordinary shares at AU$0.30 per share.
- Net proceeds will fund ongoing and future research programs and working capital.
- A new analysis of two Phase 3 trials shows that previously-treated patients with highly-active relapsing multiple sclerosis (RMS) who were treated with Novartis' Gilenya (fingolimod) had a 6x greater likelihood of achieving "no evidence of disease activity" across four key measures of disease activity compared to placebo over two years (p<0.0001). The disease status, called NEDA4, is achieved when an RMS patient has no relapses, no new MRI lesions, no MS-related brain shrinkage and no disability progression. It provides physicians with a more complete picture of an RMS patient's disease and response to therapy.
- A separate analysis of the data also confirmed that, after one year of treatment, RMS patients on Gilenya were 2x as likely to achieve NEDA4 as patients on Biogen's (NASDAQ:BIIB) Avonex (interferon beta-1a).
- The data were presented at the 67th American Academy of Neurology Annual Meeting in Washington, D.C.
- Gilenya is approved in the U.S. for the first-line treatment of RMS in adults and in Europe for adult patients with highly-active RMS.
7:52 AM| Comment!
- Inovio Pharmaceuticals (NASDAQ:INO) initiates a Phase 1 dose escalation study to evaluate the safety, tolerability and immunogenicity of its DNA immunotherapy, INO-1800, in patients with chronic hepatitis B infection. The action triggers a $3M milestone payment from co-developer Roche (OTCQX:RHHBY).
- The trial will assess INO-1800 alone or in combination with INO-9112, Inovio's IL-12-based immune activator. All patients will also be treated with standard-of-care antiviral therapies.
- In preclinical studies, INO-1800 generated strong T-cell and antibody responses that led to the elimination of targeted liver cells in mice. Investigators observed that hepatitis-B-specific T-cells exhibited a killing function and could migrate to and remain in the liver where they cause clearance of target cells without evidence of liver injury.
- About 240M people worldwide are infected with hepatitis B, contributing to 1M deaths per year. Liver cancer, a common progression of chronic hep B infection, strikes 600K people every year, killing most within five years.
- Teva (NYSE:TEVA) could make an unsolicited offer for rival Mylan (NASDAQ:MYL) as soon as today, Bloomberg reports, in what could be the drug industry's largest takeover attempt this year. Mylan has a market value of $33.3B.
- Teva has been working with Barclays on the approach and has contacted other banks about financing a potential deal.
- On Friday, Mylan said it's not interested in a sale and doesn't expect a potential combination to clear antitrust hurdles.
- TEVA +3.9%; MYL +12% premarket
- Previously: Mylan says rumored Teva marriage would not makes sense (Apr. 20 2015)
- Previously: Teva reportedly weighing bid for Mylan; shares jump (Apr. 17 2015)
Monday, April 20, 2015
- The FDA approves the use of Syneron Medical's (NASDAQ:ELOS) PicoWay picosecond laser for the treatment of pigmented lesions, the second indication for the product. The agency approved it in November 2014 for the removal of tattoos.
- PicoWay generates an ultra-short pulse (one trillionth of a second) duration that optimizes the fracturing of tattoo ink or pigmentation.
- The company launched the system in the U.S. and international markets in Q4 2014. The launch in Canada will commence this quarter.
- The FDA accepts Seattle Genetics' (NASDAQ:SGEN) supplemental Biologics License Application (sBLA) seeking approval for the use of Adcetris (brentuximab vedotin) as post-transplant consolidation treatment of Hodgkin lymphoma (HL) patients at high risk of relapse or progression. The application is designated for Priority Review with a PDUFA date of August 18.
- The data supporting the application was from a Phase 3 trial, AETHERA, that demonstrated that 16 cycles of Adcetris as consolidation therapy immediately following an autologous stem cell transplant (ASCT) extended progression-free survival (PFS) in HL patients at high risk of relapse or progression. The median PFS for the Adcetris cohort was 43 months compared to 24 months for placebo while the two-year PFS was 63% for the Adcetris arm versus 51% for placebo.
- Adcetris is an antibody-drug conjugate consisting of an anti-CD30 monoclonal antibody attached to microtubule disrupting agent, monomethyl auristatin E. It is currently cleared for the treatment of HL patients after failure of ASCT or after failure of at least two prior multi-agent chemo regimens and for the treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemo regimen.
- Adcetris accounted for all of the company's 2014 product revenue of $178.2M and 62% of its total revenues of $286.8M.
- Data from a 184-subject Phase 1/2 study assessing Immunomedics' (NASDAQ:IMMU) antibody-drug conjugate, sacituzumab govitecan, in patients with epithelial cancers showed significant and durable tumor shrinkage after treatment, including some metastatic triple-negative breast cancer patients whose whose tumors were no longer detectable by computed tomography (two of 12 patients).
- The interim results were generated from 130 patients having one of four cancer types: breast, lung, esophageal and colorectal. All failed prior therapies. The objective response rates (defined as partial responses) were 26% (n=12) for triple-negative breast cancer (n=46), 32% (n=6) for non-small cell lung cancer (n=19), 30% (n=6) for small cell lung cancer (n=20) and 13% (n=2) for esophageal cancer (n=16). The number of patients represents those that were evaluable at the time of the interim analysis.
- The disease control rates (responders plus those with stable disease) for the four groups were 74%, 74%, 55% and 56%, respectively. The cancer was deemed stable if the tumor shrank <30% or increased <20%.
- The company utilizes moderately toxic drugs conjugated to tumor-targeting antibodies instead of highly toxic agents. It believes that this is a more effective method to administer cytotoxic compounds over repeated cycles of treatment.
- MediWound (MDWD +5.5%) commences a Phase 3 study, called DETECT, evaluating NexoBrid for the removal of burn eschar (dead or damaged tissue) from patients with deep partial and full thickness thermal burns. The 175-subject trial will randomize patients to receive NexoBrid, standard-of-care or gel vehicle. The follow up periods are 12 and 24 months. The primary endpoint is complete eschar removal. Secondary endpoints include reduction in surgical burden, earlier eschar removal and blood loss. Wound closure and long-term cosmesis (appearance) will be assessed as safety endpoints.
- NexoBrid is topical pharmaceutical product that removes eschar in four hours without harming surrounding healthy tissue. It was launched in Europe in late 2013 and in Israel in mid-2014.
- Nano cap Novogen (NVGN +17.3%) continues its up move today on increased volume. Shares have ballooned six-fold since mid-December.
- At the Cancer Research Annual Meeting, data were presented on the experimental drug Cantrixil. In a recurrent disease model of ovarian cancer developed by researchers at Yale Medical School, the anti-cancer product candidate prevented tumor recurrence by 95%. According to the company, this is noteworthy because no drug candidate has shown a meaningful or durable anti-cancer effect in this particular model.
- In the model of primary disease, Cantrixil administered intraperitoneally as a monotherapy inhibited tumor growth in a dose-dependent manner, reducing the terminal tumor burden by >90% over 17 days of treatment.
- Cantrixil is a cyclodextrin envelope containing the active ingredient, TRXE-002, a small molecule pan-cancer cytotoxic agent. It is designed as an intra-cavity chemotherapy to be injected directly into the peritoneal and pleural cavities without causing local irritation or toxicity. The drug candidate is owned by Novogen subsidiary CanTx, a joint venture between Novogen and Yale University.
- St. Jude Medical (STJ +0.8%) exercises its option to acquire Menlo Park, CA-based Spinal Modulation for $175M plus additional payments based on FDA clearance of the Axium Neurostimulator System and the achievement of certain revenue targets.
- The company has had a relationship with Spinal Modulation since January 2013, when it secured exclusive rights to distribute Axium in ex-U.S. territories. It also made a $40M equity investment in the intraspinal neuromodulation therapy firm.
- St. Jude expects to complete the transaction this quarter.
- Micro cap Coronado Biosciences (CNDO -2.8%), down as much as 19% today before recovering, disclosed in a regulatory filing that it terminated development of its Trichuris suis ova program for the treatment of pediatric patients with autism spectrum disorder after a preliminary data analysis from a Phase 2a trial failed to demonstrate any signal of activity.
- The first patient has been dosed in a Phase 3 trial sponsored by Merck KGaA (OTCPK:MKGAY) and Pfizer (PFE +0.3%) to evaluate the PD-1 inhibitor avelumab in patients with advanced (stage IIIb/IV) non-small cell lung cancer whose disease has progressed after receiving platinum-based chemo. The open-label study will enroll ~650 patients across 290 sites in more than 30 countries, randomized 1:1 to receive either avelumab or docetaxel, regardless of PD-1 status.
- The primary endpoint is overall survival (OS). Secondary endpoints include overall response rate (ORR), progression-free survival (PFS) and patient-reported outcomes.
- Avelumab was discovered and developed by Merck KGaA. It entered into a strategic alliance with Pfizer in November 2014 to co-develop and co-commercialize the PD-1 inhibitor and to collaborate on up to 20 immuno-oncology clinical development programs, including combination trials, many of which will commence this year.
- Merck (MRK +1.9%) submits its supplemental New Drug Application (sNDA) to the FDA seeking approval for the use of Keytruda (pembrolizumab) for the treatment of advanced non-small cell lung cancer whose disease has progressed on or after platinum-based chemo and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present. The submission was based on data from the KEYNOTE-001 study.
- Keytruda is currently cleared for the treatment of melanoma.
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