The Friday Five – Five of the past week's pharma stories you can't afford to ignore...

Sanofi receives double positive EU opinions for MS franchise

This week Sanofi received a boost to its promising multiple sclerosis franchise from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). Lemtrada (alemtuzumab) received a positive opinion for use in relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features, and the committee granted new active substance designation (NAS) for Aubagio (teriflunomide), reversing an earlier decision. Backing of Lemtrada looks set to help overcome concerns over the risks with the drug, while the favourable label will not restrict the medicine to just second and third-line settings. The previous Aubagio NAS decision was reversed due to safety differences versus the sister compound leflunomide and is likely to alleviate pricing and market access concerns for Aubagio.

See Doubt over Sanofi drug in EU may hurt wider MS market

Merck & Co.’s insomnia therapy US approval delayed with CRL

This week Merck announced the receipt of a complete response letter (CRL) from the US Food & Drug Administration for suvorexant. In May, an advisory board panel recommended the drug on the grounds that it is both effective and acceptably safe when dosed at 15 mg to 20 mg, and the board stated that no additional studies were required for the 10-mg starting dose. However, the committee members determined that the safety data do not support the approval of suvorexant at higher dosage strengths. Merck will need manufacturing studies to advance with the lower 10-mg dose and the FDA has also asked for a 5-mg dose to be available for patients taking CYP3A4 inhibitors. Although this is a setback, which could potentially delay launch by a year, approval looks straightforward if Merck can respond to the CRL.

See also ViewPoints: Restless AdCom meeting provides few clues on commercial outlook for Merck's suvorexant

Sunovion’s Latuda expanded into bipolar disorder

Sunovion’s major therapy, Latuda (lurasidone), received a green light from the FDA this week for use in bipolar I disorder. The drug becomes the first atypical antipsychotic to be approved for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) both as monotherapy and in combination with lithium or valproate. This is a milestone for Sunovion as approval will allow expanded use of the drug outside of schizophrenia patients in the US, its original indication. However, Latuda enters a highly competitive arena, which includes established atypical antipsychotics, antidepressives and anticonvulsants, some of which are generically available. Any additional revenue uptick will be hugely beneficial to Sunovion, but it remains to be seen if the company will be able to generate a significant level of traction among psychiatrists. Latuda is also being investigated for improvements in cognition in patients with schizophrenia (NCT01173874); with no antipsychotics fully satisfying this unmet need, further expansion for use in this population would see notable revenues.

EMA recommends the first biosimilar antibodies for approval

At the end of last week the European Medicine Agency’s CHMP recommended that biosimilar versions of Johnson & Johnson and Merck’s Remicade (infliximab) be approved for use on a region-wide basis, which could lead to their gaining full regulatory clearance in the third quarter of 2013.

Although these products are not the first biosimilars to have gained approval in the EU, the eventual approval of antibodies will be an important milestone with the potential for greater commercial success owing to the much larger revenues of the originator products.

Perhaps the most important part of this news is provided by the fact that the CHMP recommended approval for these biosimilars in all of the indications that Remicade is approved in, and not just the ones for which there is data from Phase III trials that have been undertaken by Celltrion and Hospira. With much debate around whether biosimilars would gain indication extrapolation, the EMA has now confirmed that this is indeed what it is going to do.

More analysis on this story can be found here

Onyx Pharmaceuticals rejects Amgen’s overtures

On Sunday, Onyx Pharmaceuticals confirmed that it rejected Amgen’s bid of $120 per share, which was a premium of 38 percent. Amgen is reportedly motivated to acquire Onyx by a desire to expand its oncology pipeline as revenues from its anaemia drugs decline.

Of course, Amgen isn’t the only company with an interest in expanding its oncology pipeline and franchise, and analysts have suggested that Onyx could attract bids from up to a dozen companies, including Pfizer. With such a great deal of interest, and Onyx having just rejected a bid valuing the company at around $10 billion, analysts have been trying to come up with a fair value for the company. Robin Karnauskas at Deutches Bank believes that Onyx could be worth $148 per share, whilst Geoffrey Porges from Sanford C. Bernstein & Co. believes that the company could be worth as much as $180 per share.

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