Last week’s highlights include FDA panel meeting outcomes, court rulings, and regulatory updates. The clear winner was MannKind (MNKD) which saw its shares soar a whopping 73.9% on a positive panel recommendation for its experimental diabetes drug, Afrezza.
Third Time Lucky for MannKind’s Afrezza? After a choppy start to the week when concerns regarding FDA briefing documents on Afrezza surfaced, MannKind investors had a lot to cheer about – an FDA advisory panel voted in favor of approving Afrezza for type I (13-1) and type II (14-0) diabetes.
Approval would make Afrezza the first ultra rapid-acting mealtime insulin therapy in the U.S. Although the FDA is not required to follow the panel’s advice it usually does so. But the real test will be the launch and uptake of the product.
Considering the safety concerns raised in the briefing documents, we think the company will have to conduct post-marketing studies. Moreover, uptake could be slow as physicians need to be convinced about switching patients to Afrezza from currently available treatments.
FDA Panel in Favor of Cubist (CBST) Drug: Cubist investors had a good start to the week with the company receiving a favorable recommendation from an FDA advisory panel for its experimental anti-infective drug – Sivextro (tedizolid). The panel voted unanimously (14-0) in favor of approving the drug for the treatment of acute bacterial skin and skin structure infections (:ABSSSI).
This brings Sivextro a step closer to gaining approval; although the FDA is not required to follow the panel’s advice, it usually does so. The FDA action date for Sivextro is Jun 20. Shares were up 4.4%.
Once approved, Sivextro will try to take share from Pfizer’s Zyvox. Phase III data showing that Sivextro is non-inferior to Zyvox should help it capture share. Less frequent dosing and a shorter treatment period should also work in Sivextro’s favor.
The Medicines Co.’s (MDCO) Shares Tumble: Last week was not so great for The Medicines Co. – the company’s shares fell 16.5% on an unfavorable trial opinion in a patent infringement lawsuit regarding Angiomax. The company failed to prove that its patents have been infringed by Hospira. Angiomax is The Medicine’s Co.’s lead product and accounted for almost 80% of total revenues in 2013. Needless to say, the earlier-than-expected entry of generics will be a major setback for the company.
Amgen’s T-Vec Fails to Show Overall Survival: Amgen, which has of late been presenting a series of positive data on its PCSK9 inhibitor, faced some disappointment with its cancer candidate, talimogene laherparepvec (often referred to as T-Vec) failing to achieve the secondary endpoint of overall survival in a late-stage study.
Even though the primary endpoint of durable response rate was achieved, the failure to achieve overall survival is disappointing as it is an important factor for cancer treatments. Encouraging overall survival data would have boosted T-Vec’s chances of gaining approval as well as its commercial potential, especially as a monotherapy.
Safety Concern Woes for Halozyme (HALO): Halozyme shares plunged 27.3% on a safety scare related to the development of PEGPH20 for pancreatic cancer. An independent Data Monitoring Committee (:DMC) recommended that patient enrollment and dosing in an ongoing mid-stage study should be temporarily halted. The temporary halting of the phase II study due to safety signals is a matter of concern and creates uncertainty regarding the future of this program.
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Regeneron Armed with PCSK9 Data: Regeneron and partner Sanofi were not to be left behind where positive data on PCSK9 inhibitors is concerned. The companies said that there experimental PCSK9 inhibitor, alirocumab, lowered “bad” cholesterol significantly in Japanese patients.
The race to bring the first PCSK9 inhibitor is heating up. Apart from Regeneron and Sanofi, Amgen and Pfizer are developing drugs targeting this lucrative market which represents multi-billion dollar sales potential.
Celgene (CELG) Bets on Forma: Celgene expanded its relationship with Forma Therapeutics which is focused on oncology and other genetically driven therapeutic areas. The collaboration, which could see Celgene paying up to $600 million (including an upfront payment of $225 million), could ultimately result in Celgene acquiring Forma.
Partial Hold on Curis (CRIS) Study Lifted: A partial clinical hold placed by the FDA on Curis’ experimental cancer drug, CUDC-427, was lifted last week. This means that Curis can go ahead and resume enrollment of patients in a phase I study for solid tumors or lymphoma. The FDA had placed the study under partial clinical hold due to the death of a patient who had progressed to liver failure a month after CUDC-427 dosing was stopped.
Amarin-Kowa to Co-Promote Vascepa: Amarin (AMRN) is collaborating with Kowa Pharmaceuticals for the promotion of its flagship product, Vascepa, in the U.S. The agreement will more than double Vascepa sales calls and expand the target audience of primary care physicians and cardiologists.
Xtandi Filed in EU for Pre-Chemo Indication: Medivation (MDVN) and partner Astellas (ALPMY) are looking to get their prostate cancer treatment, Xtandi, approved in the EU for chemo-naïve patients. Approval in this highly lucrative market would boost sales significantly.
Gilead’s (GILD) Sovaldi Scores Again: Gilead’s hepatitis C virus treatment, Sovaldi, fared well in a late-stage study in Japan paving the way for the filing of a regulatory application there. Japan is estimated to have one of the highest rates of liver cancer in any industrialized country – a major part of these cases result from chronic HCV infection.
Japan represents a huge market for HCV with about 2 million people living with the infection. Gilead plans to file for Japanese approval by mid-2014. Sovaldi would be the first product in Gilead’s portfolio to be launched in Japan. Sovaldi is one of the most important products in Gilead’s portfolio and has multi-billion dollar sales potential.
Agenus (AGEN) Shares Slip: Agenus shares have been slipping ever since its partner, GlaxoSmithKline, decided to stop a late-stage study being conducted with MAGE-A3 cancer immunotherapeutic in non-small cell lung cancer patients. Agenus’QS-21 Stimulon was used to enhance the effectiveness of the treatment.
Prana (PRAN) Shares Plunge on Mid-Stage Data: Australia-based Prana Biotechnology saw its shares plunging 71.6% on disappointing mid-stage data on its Alzheimer's disease compound, PBT2. Developing treatments for Alzheimer’s has always been a challenge with big companies like Pfizer, Johnson & Johnson and Eli Lilly also facing setbacks. But the market is highly lucrative with several companies continuing to work on developing a treatment for this disorder.
The Week So Far:
FDA Action Date for Next Gilead HCV Drug: Gilead could well have its next HCV drug approved later this year -- the company, which had filed for FDA approval of its once-daily fixed-dose HCV cocktail treatment -- ledipasvir (NS5A inhibitor) plus Sovaldi (nucleotide analog polymerase inhibitor) – said that the combination has been accept for review. The FDA will decide on the approval status of this cocktail treatment by Oct 10.
FDA Pushes out Action Date for Afrezza: The FDA, which was supposed to deliver a response regarding Afrezza’s approval status by Apr 15, has delayed its decision by three months. So MannKind will now have to wait until Jul 15 before a decision of Afrezza is available. MannKind shares, which had surged almost 74% on a positive FDA panel, dropped 8% on the delay.
Alkermes (ALKS) Gains on Impressive Data: Alkermes shares were up on impressive top-line data from a pivotal study on its experimental schizophrenia drug aripiprazole lauroxil.
Pharmacyclics (PCYC) Seeks Imbruvica Label Expansion: Pharmacyclics has filed a regulatory application in the U.S. for its cancer drug, Imbruvica, based on data from a head-to-head study (in previously treated chronic lymphocytic leukemia patients) versus Glaxo’s Arzerra.
Agios (AGIO) Soars on Promising Early Data: Agios presented promising early data on its experimental cancer drug, AG-221. Shares were up 27.8%. AG-221 is being developed under a strategic collaboration with Celgene.
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