BioMarin mulling price of $2M – 3M for hemophilia gene therapy

In an interview at JPMorgan’s Healthcare Conference, BioMarin Pharmaceutical (BMRN +0.1%) CEO Jean-Jacques Bienaimé said that the company is exploring pricing its hemophilia A gene therapy, valoctocogene roxaparvovec (valrox), at $2M – 3M, a price range apparently acceptable to insurers considering the therapy’s benefits.

In clinical trials, treated patients experienced reductions in bleeding episodes from an average of 16.5 to zero, an effect sustained for three years.

Mr. Bienaimé also said that the company is open to alternative payment schemes such as pay-for-performance, an approach many other biotechs are using for pricey meds.

By comparison, Roche’s Hemlibra (emicizumab-kxwh), a bispecific antibody approved in the U.S. for hemophilia A in October 2018, costs almost $500K per year following the initial dose but is less expensive versus prophylactic treatments.

Barring something unexpected, BioMarin expects the FDA nod sometime in Q3.

#JPM20

https://seekingalpha.com/news/3532487-biomarin-mulling-price-of-2m-3m-for-hemophilia-gene-therapy

Abbott prevails in patent challenge by Edwards Lifesciences

The USPTO’s Patent Trial and Appeal Board has denied a petition from Edward Lifesciences (EW +0.3%) for an inter partes review of U.S. Patent No. 8,057,493 held by Abbott (ABT +0.4%) subsidiary Evalve. The PTAB determined that EW had not demonstrated a reasonable likelihood that the patent’s claims are unpatentable.

The ‘493 patent covers devices, systems and methods for tissue approximation and repair at treatment sites.

https://seekingalpha.com/news/3532481-abbott-prevails-in-patent-challenge-edwards-lifesciences

Glaxo: No immediate plans to spin off Pfizer joint venture

GlaxoSmithKline has made no plans to spin off or float its consumer healthcare joint venture with Pfizer, according to a top company executive.

Last year GSK and Pfizer merged their consumer healthcare businesses into a single joint venture, creating one of the largest over-the-counter companies in the world with major market share in important regions such as the US and China.

According to BNN Bloomberg Pfizer’s CEO Albert Bourla said this week he expects GSK to pursue an IPO in three to four years.

“This is the time that we will be able to exit from this partnership, and I’m sure that this business will have a fantastic IPO,” Bourla said.

The long-term plan has always been to spin off the joint venture into a new company, but for now that is a long way off according to GSK’s chief strategy officer.

In an interview at the JP Morgan Healthcare Conference in San Francisco, GSK’s chief strategy officer David Redfern said the UK pharma had made no firm plans for an IPO.

“No, actually we haven’t decided anything. We haven’t really thought about it,” Redfern said.

“We’ve said when we announced the deal, we expect it to separate within three years, but actually up to five years. And it’s entirely our decision.”

For now the focus is on integrating the business and growing sales, rather than a spin off or IPO.

“We don’t want it too distracted right now thinking about capital markets,” Redfern said. “Whether its an IPO or just a straight spin, all options are on the table. We’ve literally had no discussion (with Pfizer)”, he said.

The combined business has sales of about $13 billion and markets products including Advil painkillers, Tums stomach tablets, Sensodyne toothpaste, and Nicorette gum.

GSK is the majority owner and Pfizer has around a third of the business, which has been created to allow both pharma companies to focus on developing more novel drugs.

GSK has no immediate plans to spin off Pfizer joint venture

Syneos Health target upped to $74 from $62 by Baird

Maintains Outperform

https://www.benzinga.com/stock/SYNH/ratings

Unitedhealth target raised to $343 from $312 by Oppenheimer

Maintains Outperform

https://www.benzinga.com/stock/UNH/ratings

Investors see smoother path for U.S. stocks as Warren’s election odds slip

Traders are less worried about political uncertainty in the run-up to the U.S. presidential election, with former Vice President Joe Biden remaining strong in the polls while Senator Elizabeth Warren has lost ground.

Implied volatility, which measures expectations for outsized equity price moves, has fallen significantly in the past few months for healthcare, financials and energy – sectors considered at risk of disruption or increased regulation under a Democratic president.

The decline in expectations for volatility tracks the poll numbers for Warren, who is considered to be among the most left-leaning Democratic candidates. Warren’s standing peaked in October, according to Reuters/Ipsos polling, and has trailed off since then.

“We were seeing a lot more volatility in September, October, November, when the odds of Elizabeth Warren getting elected were higher,” said Chris Murphy, co-head of derivative strategy at Susquehanna Financial Group. “Joe Biden seems to be the market’s safe candidate.”

Even a boost for Senator Bernie Sanders, another progressive candidate, has had little effect on implied volatility as Biden, seen as a moderate, has maintained a position at or near the lead in several polls.

For instance, 30-day implied volatility for the Health Care Select Sector SPDR Fund has dropped to 12.2% as of Wednesday morning, from 18.9% in early October, according to data from options analytics firm Trade Alert.

“So much of the Iowa anxiety was coming at a time when Warren was trending higher,” said Michael Purves, founder of Tallbacken Capital Advisors in New York, in reference to the Iowa caucuses, the first presidential nominating contest, on Feb. 3. “That anxiety has dissipated.”

Jitters related to the Democratic presidential primaries have not entirely disappeared. CBOE Volatility Index futures expiring in late February show a bump in expectations for volatility. The futures reflect the outlook for the month-long period following that date, which encompasses Super Tuesday on March 3, when several key states, including California and Texas, hold primaries.

Still, “I would expect us to be seeing a lot more Super Tuesday positioning if there was some,” Murphy said.

Both VIX futures and the benchmark S&P 500 U.S. stock index show a significant bump in implied volatility near the Nov. 3 vote, compared to either the preceding or following periods.

“Traders have already started pricing in a hefty election risk premium” around November, wrote Mandy Xu, equity derivatives strategist at Credit Suisse in New York, in a research note on Monday.

https://www.marketscreener.com/news/Investors-see-smoother-path-for-U-S-stocks-as-Warren-s-election-odds-slip–29846763/?countview=0

Moderna up 6% after CEO interview

Moderna (MRNA +6%) jumps out the gate this morning on the heels of bullish comments from CEO Stephane Bancel on CNBC’s Mad Money with Jim Cramer pertaining to the company’s personalized cancer vaccines.

CMV vaccine candidate, mRNA-1647, poised to advance into Phase 3 development.

https://seekingalpha.com/news/3532386-moderna-up-6-after-ceo-interview