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Apart from the usual study results, last week’s top stories include the lifting of clinical holds for two experimental treatments as well as the granting of fast track and orphan drug status to a couple of candidates.

Clovis (CLVS - Snapshot Report) Down on Safety Concerns: Clovis’ shares slumped 19.9% on safety concerns about its experimental lung cancer treatment, CO-1686. Clovis had presented encouraging data on the treatment at the annual meeting of the American Society of Clinical Oncology (ASCO). However, about 22% of patients were found to have high sugar, which is associated with diabetes. Clovis is trying to bring its cancer treatment ahead of AstraZeneca which has a similar candidate in its portfolio. But safety concerns could put a lid on progress.

Another Hemophilia Win for Biogen (BIIB - Analyst Report): Biogen now has another hemophilia treatment in its portfolio with the FDA approving Eloctate (hemophilia A). Hemophilia A, a rare, chronic, genetic disorder under which blood clotting ability is impaired, can lead to recurrent and extended bleeding episodes.

Earlier this year, Biogen’s hemophilia B treatment Alprolix was approved in the U.S. A convenient dosing schedule (supported by a longer duration of action and a suitable safety profile) could help these products capture share from existing products in the hemophilia market.

FDA Lifts Clinical Hold, Halozyme (HALO - Snapshot Report) Soars: The FDA lifted its clinical hold on Halozyme’s mid-stage study on PEGPH20 for pancreatic cancer. This removes uncertainty regarding this program which had run into trouble earlier this year due to safety concerns. The study will continue under a revised protocol. Shares were up 12%.

Partial Clinical Hold on Ariad (ARIA - Snapshot Report) Study Lifted: Ariad’s investors finally had something to cheer about with the FDA lifting a partial clinical hold on the company’s phase II study of Iclusig in patients with refractory metastatic and/or unresectable gastrointestinal stromal tumors. New patients can now be enrolled in this study. Ariad also presented initial data which indicate Iclusig’s anti-tumor activity in patients with advanced GIST, particularly in patients with KIT exon 11 mutations. Shares were up 7.4%.

Other Developments:

Fast Track Status for GW Pharma: GW Pharma gained fast track status for its experimental treatment, Epidiolex, for Dravet syndrome. Shares were up 4.6%.

Fast track designation is usually granted to drugs being developed for the treatment of serious conditions, which have unmet medical need. Dravet syndrome is a rare and catastrophic form of childhood epilepsy, for which no cure exists at present.

With the designation, the development and review process could be speedier with more frequent and timely communication and meetings with the FDA. The candidate could also be granted priority review.

Orphan Drug Designation for Momenta’s Necuparanib: The FDA granted orphan drug status to Momenta’s experimental pancreatic cancer treatment, necuparanib. This designation is given to drugs being developed for rare diseases/disorders which affect less than 200,000 people in the U.S. The development of treatments for pancreatic cancer is extremely tough and challenging. Incentives that come with orphan drug status include federal grants, tax credits, waiver of PDUFA filing fees and seven-year marketing exclusivity following approval.

Vanda’s Hetlioz Accepted for EU Review: Vanda saw its shares soaring (25.3%) on news that its marketing application for insomnia treatment, Hetlioz, has been accepted for review in the EU. EU approval would boost the product’s sales potential quite a bit. Non-24-hour sleep-wake disorder, the indication for which the company is seeking approval, is estimated to affect about 130,000 people in the EU.

Incyte’s Immunotherapy Looks Promising: Incyte presented encouraging data on its immunotherapy INCB24360. 42% of melanoma patients being treated with ‘360 plus Yervoy achieved an objective response and 75% achieved disease control. Complete response was achieved by one patient. These results look good and support continued development of the combination.

Puma Plunges on Data: Puma’s shares plunged 25.3% on data from a breast cancer study on PB272 (neratinib). The efficacy results were modest with the incidence of diarrhea being pretty high.

The Week So Far

The week so far has been highly eventful with the highlight being Merck’s announcement that it will acquire Idenix for $24.50 per share, more than three times the company’s value before the deal was announced.

Idenix Shoots Up on Acquisition News: Idenix’s shares skyrocketed 229.05% on news that it will be acquired by pharma giant, Merck.

FDA Pushes Back Orexigen (OREX - Analyst Report) Action Date: Orexigen had a major regulatory event lined up today – the FDA was supposed to deliver a decision regarding the approval status of its experimental obesity treatment – NB32. However, the action date has been pushed back by three months to Sep 11.

Dendreon CEO to Leave Mid-August: Dendreon, which is going through challenging times, said that CEO John H. Johnson will be leaving mid-August.

Good Times for Achillion: Achillion’s shares soared significantly over two consecutive days – 47.6% on speculation that it could be a takeover target like Idenix and 83.3% on the lifting of a clinical hold on its NS3/4A protease inhibitor, sovaprevir.

Receptos (RCPT - Snapshot Report) Shoots Up on Promising Data: Receptos’ shares are up a whopping 36.8% on positive mid-stage data on its experimental oral multiple sclerosis treatment, RPC1063.

Isis Earns Couple of Milestone Payments: Isis continues to progress with its pipeline and earning milestone payments related to the same. The company earned two milestone payments this week – one from Biogen and the other from AstraZeneca both on the initiation of phase I studies.

Natpara Advisory Panel Date Pushed Back: NPS Pharma said that the advisory panel meeting for Natpara will be held tentatively on Sep 12 instead of the earlier expected date of Jul 24. However, the FDA action date of Oct 24 remains the same. NPS Pharma is looking to get Natpara approved for the treatment of hyperparathyroidism – this is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone.

What Next?

Vertex has an important pipeline event coming up – highly awaited results from two pivotal phase III studies (TRAFFIC and TRANSPORT) in cystic fibrosis patients should be out shortly. Positive results would allow Vertex to file for U.S. and EU approval in the second half of the year.

Meanwhile, next week, the FDA will decide whether it should approve Cubist’s experimental anti-infective drug – Sivextro. Chances of gaining approval look high given an FDA panel voted unanimously (14-0) in favor of approving Sivextro for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The FDA action date is Jun 20.
 

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