Last week, the spotlight was firmly on InterMune (ITMN), which was an outperformer with shares shooting up and reaching a 52-week high on impressive late-stage data on the company’s lung disease drug.
InterMune Scores Huge Win in Phase III Study: InterMune’s shares skyrocketed 170.8% on impressive data from the company’s phase III study on its lung disease drug, Esbriet. Results from the phase III ASCEND study showed that Esbriet significantly reduced idiopathic pulmonary fibrosis (IPF) disease progression.
Esbriet, currently approved in the EU, is yet to gain U.S. approval. With the ASCEND data in hand, InterMune is set to resubmit an NDA early in the third quarter. The results are compelling enough for the company to succeed in gaining FDA approval.
Approval in the U.S. would boost sales of the drug significantly. Esbriet sales were $70.3 million in 2013. However, it is yet to be seen how Esbriet compares with Boehringer Ingelheim’s BIBF-1120 (nintedanib), which has shown potential efficacy in IPF. BIBF-1120 is in a couple of phase III studies for IPF with results due in the first half of 2014.
Orphan Drug Designation for Soliris – Again: Alexion’s (ALXN) Soliris was granted orphan drug designation in the EU for yet another indication: the prevention of delayed graft function (:DGF) after solid organ transplantation. The designation, which is granted to drugs being developed for diseases or conditions that affect ≤ 5 in 10,000 people in the EU, provides benefits and incentives including a particular period of marketing exclusivity to the developing company.
Regeneron’s Eylea Under FDA Review: Regeneron continues to make progress with its label expansion efforts for eye drug, Eylea. The FDA has granted standard review to Eylea for an additional indication – the treatment of macular edema following branch retinal vein occlusion (:BRVO). The FDA will issue a response by Oct 23. Eylea is already approved for two indications and under review for another indication (diabetic macular edema) apart from BRVO.
Breaking Down VIVUS’ Results: Licensing revenue helped VIVUS post a lower loss as well as significantly higher fourth quarter revenues. Despite this, shares fell 13.2% as investors remained focused on obesity drug Qsymia’s performance. Qsymia sales improved sequentially but not enough to ensure investor confidence in the product’s ability to gain traction. Prescriptions are yet to bounce back following the post-holiday season and a partnership deal for Qsymia is yet to materialize.
Investors also expressed disappointment in Arena’s (ARNA) fourth quarter results sending the shares down 3.8%. Sales of obesity drug, Belviq, continued to disappoint. Partner Eisai is putting in a lot of effort (doubling of sales force, DTC campaign) to drive sales. However, it is difficult to get physicians to prescribe obesity treatments. Moreover, new competition could enter the market in the form of Orexigen’s Contrave.
Medivation (MDVN) Shares Slip on Xtandi Guidance: Medivation saw its shares slipping 14.9% despite delivering better-than-expected fourth quarter results. The reason for the decline was the 2014 sales guidance for prostate cancer treatment, Xtandi, which was below expectations. The company said that it expects Xtandi U.S. sales of $500 million - $535 million in 2014.
Fourth quarter 2013 Xtandi sales in the U.S. were $126.1 million. Going by that number and the lower end of the guidance range, it would seem that quarterly sales of Xtandi in the U.S. could remain flat sequentially.
Based on this, the first question that comes to mind: is the company being conservative or is demand for Xtandi slowing down? Chances are that guidance could very well be on the conservative side especially if Xtandi’s label is expanded into the chemo-naïve patient population later this year.
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Hyperion Shares Up on Mid-Stage Data: Hyperion (HPTX) saw its shares surge 13.4% on positive phase II data on its hepatic encephalopathy (HE) candidate, glycerol phenylbutyrate (:GPB). Patients experiencing HE events declined significantly compared to placebo (21% versus 36%). Moreover, the time to experience the first HE event was lengthened in the case of GPB. Hyperion should be in a position to move the candidate into late-stage development later this year/early next year.
The Medicines Co.’s Oritavancin Under EU Review: The Medicines Co.’s investigational antibiotic, oritavancin, has been accepted for review in the EU. Oritavancin is currently under review in the U.S. as well with a response expected by Aug 6.
Merck Backs Out of ARIAD (ARIA) Deal: Merck terminated its license agreement with ARIAD for the worldwide development and commercialization of the latter’s experimental cancer treatment, ridaforolimus. The deal, which dates back to 2010, will come to a close in November.
Merck’s decision doesn’t really come as a surprise given ridaforolimus’ regulatory history. In Jun 2012, ridaforolimus failed to gain FDA approval with the agency asking for additional studies. Then in Nov 2012, Merck withdrew its regulatory application for the candidate in the EU as the available data would not be sufficient to gain approval. So the development of ridaforolimus is now in ARIAD’s hands.
The Week So Far:
Regeneron’s Eylea Closer to DME Approval in Japan: Regeneron and partner Bayer are looking to get their eye drug, Eylea, approved in Japan for the treatment of patients with diabetic macular edema (:DME). Marketing applications for this indication have been submitted in the U.S. and the EU as well.
Pipeline Setback Overshadows Xoma’s Earnings Report: Xoma’s fourth quarter results were overshadowed by the company’s announcement that it will not be moving gevokizumab into phase III studies for erosive osteoarthritis of the hand.
Dendreon (DNDN) Soars on Fourth Quarter Results: Dendreon’s shares surged 14.9% on better-than-expected fourth quarter results. Moreover, the company said that it will start marketing its cancer vaccine, Provenge, in Europe this year.
NICE Questions Soliris Pricing: U.K.'s cost-effectiveness watchdog – NICE – has asked Alexion why its atypical hemolytic uremic syndrome (aHUS) treatment, Soliris, costs so much. aHUS is estimated to affect about 200 people in England. The company may well have to come up with higher discounts to smoothen the pricing and reimbursement process.
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