Friday Five - The week in review

Pfizer to review its future in consumer health

Pfizer announced it is reviewing strategic options for its consumer healthcare business, including a full or partial separation of the unit through a spin-off, sale or other transaction. Although the company added that it may also decide to retain the business, which generated sales of approximately $3.4 billion last year, analysts suggested this was the least likely option

Analysts at Barclays noted that "should Pfizer complete a consumer transaction, we suspect that the proceeds would most likely be allocated to finding additional growth assets – particularly in oncology – for the innovative (pharmaceuticals) business." Selling consumer is perhaps not agenda setting, however; analysts at Credit Suisse write "we do not believe Pfizer needs the proceeds from a consumer healthcare sale to pursue either large-scale or small-scale M&A. We do, however, continue to believe PFE would like some clarity on the potential outcome of US corporate tax reform before it would pursue a transformative deal."

That said, they add that "sale of consumer would help streamline Pfizer's focus on its core biopharmaceutical business and allow for it to then proceed more neatly towards trying strengthening both sides of the business (innovative and established pharma products), while keeping the option to split into two separate companies open for the future."

Analysts at Deutsche Bank suggest the consumer business could fetch $15 billion, adding "we would not be surprised if Pfizer has already received indications of interest" from potential suitors.

Trends to watch in psoriasis

Fuelled by a number of new drug launces in recent years, the psoriasis market is one of pharma's most dynamic. A Physician Views survey run by FirstWord earlier this week highlights a number of product-level trends worth watching over the next few quarters; among them the competitive threat posed to Novartis' Cosentyx from Eli Lilly's Taltz in the US market and significant prescriber enthusiasm for Johnson & Johnson's recently approved Tremfya – Physician Views Poll Results: Dermatologists identify the standout franchises in psoriasis.

…and multiple sclerosis

The multiple sclerosis market is likely to be shaped over the next few years by factors relating to products old and new. The FDA recently approved a first generic version of Copaxone 40mg and we are snap-polling neurologists to ascertain how this will impact treatment patterns

At the other end of the spectrum, Roche's Ocrevus is the newest market entrant and has achieved a strong initial launch based on second-quarter results. Analysts at Jefferies expect the antibody to deliver another strong quarter in sales when Roche announces its Q3 results later this month. Nevertheless, Ocrevus was caught up in the recent confusion emanating from the FDA's newly navigable adverse events database and Roche has been keen to point out that Ocrevus has yet to be associated with any cases of progressive multifocal leukoencephalopathy (PML) in the US. A single case in Europe has been investigated, but the patient in question had previously been treated for three years with Tysabri; a treatment with known PML risk. A key opinion leader told FirstWord this week that PML cases would likely appear in time with Ocrevus, but that overall incidence is likely to be low based on data from Roche's pivotal-stage studies. Patients moving from other therapies – such as Tysabri – to Ocrevus also needs to be taken into consideration, he added – KOL Views Results: Leading neurologist says fears about Ocrevus’ PML risk are overblown.

Key licensing deals

Merck & Co. entered a deal potentially worth $750 million to develop KalVista Pharmaceutical's experimental drug KVD001 for the treatment of diabetic macular oedema (DME). The agreement includes an upfront payment of $37 million and Merck will acquire a 9.9-percent stake in KalVista. KVD001, which is due to advance into Phase II testing by year-end, is the most advanced kallikrein inhibitor in development for DME, according to FirstWord research.

Under license from ActiveSite Pharmaceuticals, AntriaBio is developing an oral, small-molecule kallikrein inhibitor in preclinical testing, while a partnership between Bicycle Therapeutics and Thrombogenics is developing the peptide THR-149, a plasma kallikrein inhibitor, for DME; this molecule is also yet to move into clinical testing. Earlier this month, Verseon presented promising preclinical data for its plasma kallikrein inhibitors.

AbbVie picked up an option to programmes under development at Turnstone Biologics, a Canadian oncolytic virus company first launched by Versant Ventures in 2015. Taking the basics from oncologic viruses like Amgen's Imlygic (previously known as T-Vec), it is using a Maraba-derived virus to lyse cancer cells and release immuno-stimulatory neo-antigens. But it has also integrated a tumour antigen, in this case, MAGEA3, as a targeting mechanism to specifically direct T cells towards solid tumours. Leveraging that unique take on oncolytic viruses, the company describes itself as the first to combine an oncolytic virus with a cancer vaccine – more analysis here.

Regulatory updates

The FDA approved Flexion Therapeutics' Zilretta for osteoarthritis knee pain – see Physician Views Poll Results: Prescribers expect Flexion's Zilretta to be a hard sell.

AstraZeneca's Tagrisso was awarded FDA breakthrough therapy status in first-line EGFR-mutated non-small-cell lung cancer and Imfinzi was accepted for review in Europe for the treatment of stage III unresectable NSCLC – see ViewPoints: AstraZeneca's key cancer hopefuls gain regulatory momentum.

Merck & Co. decided not to file the CETP inhibitor anacetrapib with regulators – ViewPoints: Merck & Co. accedes to commercial realities with anacetrapib.

The FDA issued a complete response letter to AcelRx Pharmaceuticals in response to its marketing application seeking approval of Dsuvia for the treatment of pain.

Chinese drug approvals should become easier, and quicker, for foreign players, with new proposals allowing exclusive use of overseas trial data to support regulatory applications – see Spotlight On: More momentum in China's bid to accelerate new drug approvals but IP concerns remain.

The FDA  granted priority review to Eli Lilly's Verzenio as a first-line treatment for HR+/HER2- breast cancer – see Physician Views Poll Results: Like Kisqali, there is some room for Verzenio in an Ibrance-dominated market. However, Eli Lilly also confirmed this week that Verzenio failed to improve overall survival in patients with KRAS mutated NSCLC.

Johnson & Johnson confirmed it filed a new drug application with the FDA for apalutamide, for non-metastatic castration-resistant prostate cancer - ViewPoints: Johnson & Johnson puts cart before horse with apalutamide – time must be of the essence

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