Friday Five – Your weekly pharma review

A spate of M&A, but Big Pharma remains on the sidelines (for now)

The past week has seen a number of notable acquisitions.

Horizon Pharma has expanded its portfolio of rare disease drugs with the $800-million acquisition of Raptor Pharmaceuticals. Through the deal, Horizon will gain access to the nephropathic cystinosis therapy Procysbi (cysteamine bitartrate) and Quinsair (levofloxacin), which is used to treat chronic pulmonary infections due to Pseudomonas aeruginosa in adults with cystic fibrosis.

Analysis: ViewPoints: Horizon, Raptor deal a vestige of a different time – but investors don't mind

Allergan announced it is to acquire Vitae Pharmaceuticals for $639 million. With Vitae's most advanced assets in Phase II development for psoriasis and atopic dermatitis, the deal is focused on the dermatology market – a core focus of Allergan's existing portfolio – but further enhances the company's reputation in drug development (ViewPoints: Saunders' pricing promise further evidence of Allergan's upward mobility?).

Analysis: ViewPoints: Allergan/Vitae deal keeps dermatology in shop window

Analysts and investors are nevertheless hopeful that Big Pharma's need to replenish pipelines will see larger deals announced in the coming weeks and months, particularly in light of Pfizer's recent $14-billion acquisition of Medivation. That deal offers another benchmark insofar as the value of Medivation partially reflected its PARP inhibitor talazoparib. As a result, other PARP developers – notably Tesaro and Clovis Oncology – are being touted increasingly frequently as takeout candidates.

Analysis: KOL Views: PARP inhibitors here to stay, says leading oncologist and ViewPoints: Tesaro keeps itself in the spotlight ahead of key ESMO presentation

Can others ride in Jardiance's slipstream?

Later this month, the FDA is expected to rule on whether to include a cardiovascular (CV) benefit claim and/or data on the labelling for Boehringer Ingelheim and Eli Lilly's SGLT2 inhibitor Jardiance, following positive outcome of the EMPA-REG study last year. Earlier this year, an FDA advisory committee voted very closely in favour of updated labelling.

As analysts look to remodel their outlook for the diabetes market, there are two key trends pulling in opposite directions; while intensified pricing pressure in the basal insulin segment represents an increasingly prominent headwind – reflected perhaps by recent management changes at Novo Nordisk – growth should be stimulated by the CV benefit demonstrated by Jardiance and Novo's GLP-1 agonist Victoza.

Spotlight On: Analysts rush to remodel the diabetes market as Novo Nordisk is forced to play the pricing game

Offering oral dosing, the SGLT2 class looks poised for particularly strong growth; this commercial opportunity is significant enough to prompt an alliance between Pfizer and Merck & Co., who on Thursday presented positive Phase III data for their co-developed therapy ertugliflozin. They hope to submit the drug by year-end and secure approval in 2017.

With a number of other SGLT2s on the market already, the field will be crowded, so movement into earlier lines of therapy and perception (until subsequent read-out from other outcomes studies) that Jardiance's CV benefit represents a class effect will be key to driving growth.

Sanofi and Lexicon hope to differentiate their own offering by targeting both SGLT2 and SGLT1, and the latter saw its share price rise as much as 48 percent late last week when positive top-line Phase III data for sotagliflozin in type 1 diabetes was confirmed (ViewPoints: Sotagliflozin clears Lexicon's extra high Phase III hurdle in type 1 diabetes).   

The latest Physician Views

Ahead of the FDA ruling on Jardiance's CV effect, FirstWord is currently polling endocrinologists and primary care practitioners about their use of the SGTL2 inhibitor class and the potential impact of a label change for Boehringer Ingelheim and Eli Lilly's product; results should be available to FirstWord Pharma PLUS subscribers early next week.

Ahead of this week's ECTRIMS congress in London, FirstWord polled MS-treating neurologists about their anticipated future use of Roche's Ocrevus (ocrelizumab), which is frequently touted as the biggest asset in biopharma's late-stage pipeline. Approval is expected in late 2016/early 2017 and the omens for commercial success look good (Physician Views Poll Results: Expectation remains high for Roche's ocrelizumab in multiple sclerosis).

FirstWord has also polled US oncologists this week about their use of Roche's Alecensa in second- and first-line ALK-positive non-small-cell lung cancer (NSCLC) and their assessment of data from the J-ALEX study in treatment-naïve patients, which was presented at this year's ASCO annual meeting in June.

Business development

A 12-month old collaboration between Sanofi and Verily Life Sciences focused on health outcomes in diabetes has evolved into a formal joint venture called Onduo, the two companies have confirmed. Sanofi will make a cash investment of $248 million, with Verily investing an equivalent amount.

Analysis: Spotlight On Interview: FirstWord speaks to Joshua Riff, CEO of Onduo – Sanofi and Google's joint venture in diabetes

Pfizer announced it has in-licensed ONC-392, a preclinical anti-CTLA4 monocloncal antibody, from OncoImmune in a deal worth potentially up to $250 million. In 2011, Pfizer out-licensed the CTLA4 inhibitor tremelimumab to AstraZeneca; that drug is currently being evaluated in combination with PD-(L)1 therapy for the first-line treatment of non-small-cell lung cancer.

The Financial Times reported this week that Takeda has reportedly set aside between $10 billion and $15 billion for acquisitions to boost its presence in the US market.

Intarcia announced it has raised $215m in additional financing this week. Combined with future milestone payments, this will fund the launch of Intarcia's implanatable diabetes treatment ITCA-650. Management expects to file an NDA for the product in the next 30-60 days. Spotlight On Interview: The man looking to revolutionise diabetes – FirstWord speaks to Intarcia Therapeutics CEO Kurt Graves

R&D/Regulatory updates

Aerie Pharmaceuticals reported new clinical data showing that the addition of latanoprost to its proprietary drug Rhopressa was more effective at treating glaucoma than either component therapy. Aerie is developing the combination under the brand name Roclatan. Earlier this month the company confirmed it has submitted a new drug application for Rhopressa to the FDA. Buoyed by the potential blockbuster status of Rhopressa and the new clinical data for Roclatan, the company's share price was up 72 percent in pre-market trading on Thursday.

AcelRx Pharmaceuticals announced positive Phase III data for ARX-04 for the management of moderate-to-severe acute pain in post-operative study patients, including elderly patients and those with organ impairment. AcelRx now plans to resubmit ARX-04 with the FDA, with shares up 22 percent in response to the news.

Celgene released a somewhat ambiguous press release regarding much anticipated Phase Ib endoscopy data for its experimental Crohn's disease treatment mongersen (ViewPoints: Celgene investors and analysts left waiting by Crohn's disease drug update).

Eisai will launch a new research division based in Andover, Massachusetts, which will focus on Alzheimer's disease, immuno-oncology and autoimmune R&D. It will be staffed by a team of 90.

GlaxoSmithKline announced EU regulatory submission for sirukumab in rheumatoid arthritis; an application with the FDA has yet to be filed ( ViewPoints: EULAR – Sirukumab scores, but can it disrupt?).

At ECTRIMS Roche presented updated findings from the OPERA I and OPERA II studies (in relapsing remitting multiple sclerosis) and the ORATORIO trial (primary progressive MS) for ocrelizumab.

Tesaro confirmed fast track regulatory status for the PARP inhibitor niraparib with the FDA, and initiation of a rolling NDA submission as a second-line maintenance treatment for certain ovarian cancer patients.

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