The biotech selloff continued last week with NASDAQ Biotechnology declining 4.46% and the NYSE ARCA Biotech Index declining 5.01% at the end of the week. Even though some companies came up with positive developments, overall sentiment remained bearish.
FDA Action Date for Next GIlead ( GILD ) HCV Drug: Gilead could well have its next hepatitis C virus (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. Approval would make this combination the first oral treatment for HCV patients with genotype 1 infection to be available in the U.S. The important thing is that patients would not need to take interferon or ribavirin (RBV), which are usually associated with greater side effects.
But competition is not far behind. Earlier this year, AbbVie had provided data from four additional studies that evaluated its all-oral, interferon-free therapy with/without RBV in the same patient population. AbbVie followed up with impressive data at the recently held International Liver Congress.
AbbVie remains on track to file for its HCV treatment early in the second quarter of 2014 and expects to gain approval this year.
Both treatments look effective with high cure rates. But Gilead's treatment is once daily while AbbVie's will require more frequent dosing. However, eventually pricing will play a role as well in share uptake.
Gilead should also watch out for Merck's combination treatment.
FDA Pushes out Action Date for MannKind's ( MNKD ) 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.
The delay should not come as a huge surprise - the FDA has a lot of information to sift through before it can arrive at a decision. Although an FDA advisory panel voted in favor of approving the drug, there are some concerns regarding safety. So the FDA will need some time to decide on the label as well as post-marketing requirements.
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. The candidate was also found to be safe and well-tolerated. With the once-monthly injection achieving the primary as well as secondary endpoints in the study, Alkermes is set to file for FDA approval in the third quarter.
The schizophrenia market is pretty crowded given the presence of several oral antipsychotic drugs. However, of late, the treatment landscape is changing with doctors recognizing the advantages of long-acting injectable antipsychotics. This may work in aripiprazole's favor given its once-monthly dosing option (which provides dosing flexibility and enhances current treatment options). But then, it does not have first-mover advantage as other once-monthly dosing options are already available.
Pharmacyclics 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 -- CLL -- patients) versus Glaxo's Arzerra.
An interim analysis from the study earlier this year showed a statistically significant improvement in progression-free survival as well as a statistically significant improvement in overall survival in the Imbruvica arm. Imbruvica, which has multi-billion dollar potential, is already approved for mantle cell lymphoma and CLL.
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Agios Soars on Impressive Early Data: Agios presented promising early data on its experimental cancer drug, AG-221. Results showed complete remissions, reduction of 2HG (2-hydroxyglutarate), a favorable safety profile and effects on cellular differentiation providing proof-of-principle for AG-221's novel mechanism of action. Shares were up 27.8%. AG-221 is being developed under a strategic collaboration with Celgene.
Intercept Shines at EASL: Intercept put on a good show at the International Liver Congress of the European Association for the Study of the Liver (EASL). The company presented new data on obeticholic acid (OCA) for the treatment of primary biliary cirrhosis, an autoimmune liver disease estimated to affect about one in 1,000 women above the age of 40.
The company, which had already presented positive data on OCA from the phase III POISE study, said that OCA also brought about a highly statistically significant reduction in alkaline phosphatase (ALP) as early as two weeks. Intercept intends to file for approval by year end.
FDA Clinical Hold for Halozyme Study: Shortly after Halozyme said that it is temporarily halting patient enrolment and dosing in an ongoing mid-stage study being conducted with PEGPH20 for pancreatic cancer, the FDA announced a clinical hold. Shares were down 2%.
A clinical hold is an order issued by the FDA under which the sponsor of the study is asked to delay a proposed trial or suspend an ongoing trial. 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.
The Week So Far:
Additional Exclusivity for BioMarin's ( BMRN ) Kuvan: BioMarin's Kuvan will now enjoy an additional six months of exclusivity. Kuvan, which is approved for a rare genetic condition that is estimated to affect at least 50,000 diagnosed patients under the age of 40 in the developed world, will now enjoy exclusivity up to Jun 2015. Kuvan is an important product in BioMarin's portfolio accounting for about 30.5% of total sales in 2013.
Promising Data on Lexicon's ( LXRX ) Diabetes Candidate: Lexicon Pharmaceuticals presented positive top-line data from a mid-stage study on its type I diabetes candidate LX4211.
Next week, several major biotech companies will be reporting first quarter results the most important being Gilead. With so much being discussed about Sovaldi and the biotech selloff being triggered by Sovaldi-related pricing concerns, Gilead's first quarter report is a highly-awaited event. Other biotech companies reporting next week include Cubist, Amgen ( AMGN ) , Biogen ( BIIB ), The Medicines Co. ( MDCO ), Celgene ( CELG ) and Alexion ( ALXN ).
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