The management of regulatory affairs essentially contributes to the overall success of new drug development – both at early pre-marketing stages and at all times post-marketing. This means that a biotech or pharma company’s regulatory affairs personnel will be heavily involved in all stages of new drug development both prior to and after an FDA approval.
That’s why its worth pointing out that just yesterday, small cap cannabinoid prodrug pharmaceutical stock Vitality Biopharma, Inc. (OTCQB: VBIO) announced the appointment of Tracy Rockney, J.D. to the position of Senior Regulatory Advisor. In addition to being the Co-Founder & Chief Operating Officer of OneSource Regulatory, a regulatory consulting firm, Rockney was previously:
From May 2010 to May 2015, she was the VP, Regulatory Affairs at AbbVie Inc (NYSE: ABBV) leading the executive functions related to regulatory policy and intelligence. From August 1993 to January 2005, she held positions of increasing responsibility with Pfizer Inc (NYSE: PFE), formerly Wyeth. From January 2005 to April 2010, she held positions with Shire PLC (NASDAQ: SHPG), including serving as Senior Director, Regulatory Affairs. This included responsibilities as Therapeutic Area Head for Shire’s Gastrointestinal Business Unit, Regulatory Advertising & Promotion and CMC. Rockney led the regulatory team and negotiations with the FDA for LIALDA which are part of the drug class of aminosalicylates that are now part of the clinical standard-of-care for treating inflammatory bowel disease. LIALDA™ was found to be effective in Phase 3 trials for inducing remission of active mild-to-moderate ulcerative colitis after eight weeks of treatment. LIALDA™ (also now marketed as Mezavant®) had 2016 U.S. sales of $714 million – up 16% relative to 2015 sales.
Rockney’s work for Shire is of particular interest to Vitality Biopharma which has developed a new class of cannabinoid prodrugs (medications or compounds that, after administration, are converted within the body into a pharmacologically active drug), known as cannabosides, which upon ingestion can enable the selective delivery of THC and cannabidiol (CBD) to the gastrointestinal tract. Cannabosides could provide therapeutic benefits for inflammatory bowel disease while eliminating or reducing drug psychoactivity.
Best Biotech Stocks To Buy Right Now: ARIAD Pharmaceuticals Inc.(ARIA)
Advisors’ Opinion:
- [By Lisa Levin]
Healthcare shares gained around 0.73 percent in trading on Monday. Meanwhile, top gainers in the sector included Ariad Pharmaceuticals, Inc. (NASDAQ: ARIA), and VCA Inc (NASDAQ: WOOF).
Best Biotech Stocks To Buy Right Now: Amgen Inc.(AMGN)
Advisors’ Opinion:
- [By Todd Shriber, ETF Professor]
Several big-name biotech companies step into the earnings confessional starting in the middle of the week, with Amgen, Inc. (NASDAQ: AMGN), Anthem Inc (NYSE: ANTM), and Celgene Corporation (NASDAQ: CELG) among the companies in play. That could bring opportunity with the Direxion Daily S&P Biotech Bull 3X Shares (NYSE: LABU) and the Direxion Daily S&P Biotech Bear 3X Shares (NYSE: LABD).
- [By Tom Gentile]
After the Senate scored the votes on Tuesday to review a plan for repealing or repealing and replacing what’s come to be known as Obamacare, we saw a mixed-bag reaction from healthcare stocks. Even some of the bulletproof ones, like Amgen Inc. (Nasdaq: AMGN), closed lower from their opening highs.
- [By Ben Levisohn]
Amgen (AMGN) has tumbled 3.6% to $158.65 after beating earnings forecasts but missing on sales.
Buffalo Wild Wings (BWLD) has dropped 3% to $157.51 after its earnings fell short of the Street consensus.
Best Biotech Stocks To Buy Right Now: Alnylam Pharmaceuticals Inc.(ALNY)
Advisors’ Opinion:
- [By Brian Orelli]
Alnylam Pharmaceuticals (NASDAQ:ALNY) jumped as much as 14.5% today after announcing earnings after the bell yesterday. As a development-stage biotech, it wasn’t the revenue or the earnings that caused the spike, but the progression of Allnylam’s pipeline.
- [By Cory Renauer]
Treating diseases that have a genetic component by altering the expression of the responsible genes is a promising new field of medicine, but it has been much less straightforward than biopharmaceutical companies had expected. Two contenders in this area, Alnylam Pharmaceuticals (NASDAQ:ALNY) and Ionis Pharmaceuticals (NASDAQ:IONS), saw a mix of setbacks and success in 2016.
- [By Lisa Levin]
Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) shares shot up 53 percent to $114.87 after the company impressed investors with encouraging data from a phase 3 clinical trial. Alnylam, a company dedicated towards treating a wide range of debilitating diseases through ribonucleic acid (RNA) interference (RNAi) therapeutics, said after Tuesday's market close that a phase 3 study called APOLLO met its primary efficacy endpoint and all secondary endpoints.
- [By Chris Dier-Scalise]
On Thursday, the Vetr crowd downgraded Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) from 4.5 stars (Strong Buy), which was issued two days ago, to 3.5 stars (Hold). Crowd sentiment for Alnylam at the time of the downgrade was edging positive, with 66 percent of Vetr user rating bullish.
- [By Ben Levisohn]
Yesterday, after markets closed, it was announced that US Federal District Court Judge Sue Robinson ruled to issue a permanent injunction against Praluent, the PCSK9 mAb for hypercholesterolemia from partners Regeneron and Sanofi, due to infringement of patents from Amgen. The court has imposed a 30-day suspension (stay) on the injunction to allow for settlement or appeal of the District Court decision. Sanofi and Regeneron have announced their intent to appeal the ruling to the US Court of Appeals for the Federal Circuit (CAFC). The injunction decision is consistent with our counter-consensus published views communicated on 25 January 2016 (“Downgrade to Sell on evidence of likely infringement of Amgen’s PCSK9 patents”) and subsequently. Based on consultation with expert legal counsel, we now put >75% probability Amgen will prevail on appeal and/or Praluent is ultimately removed from the US market, and/or Amgen achieves a settlement substantially in its favor. We currently model $3.3 bn in non-risk-adjusted 2022E US revenues for Praluent, while consensus models $1.2 bn in 2022E US revenues. We reiterate our view from 25 January 2016 to preferentially own Amgen, The Medicines Company (MDCO) (Buy), and Alnylam (ALNY) (Buy) over Regeneron for exposure to PCSK9 inhibitor market dynamics as outcomes trials approach.
Best Biotech Stocks To Buy Right Now: Medivation Inc.(MDVN)
Advisors’ Opinion:
- [By Ben Levisohn]
Medivation (MDVN) has soared 20% to $80.41 after agreeing to be purchased for $14 billion, or $81.50 a share, by Pfizer (PFE). Pfizer has declined 0.7% to $34.75.
- [By Ben Levisohn]
Reports suggest that Gilead Sciences (GILD) and Celgene (CELG) have joined the bidding process forMedivation (MDVN), one that already includes (maybe) Amgen (AMGN), and of course Sanofi (SNY), which is trying to throw out Medivation’s board. Of the three biotech giants, Citigroup’s Robyn Karnauskas and team argue that Amgen is best positioned to win the battle. They explain why:
- [By Ben Levisohn]
Well, it looks like Medivation (MDVN) now has five suitors after reports that Amgen (AMGN) is joining Pfizer (PFE), Sanofi (SNY), AstraZeneca (AZN) and Novartis (NVS) in considering a bid. Maxim’s Jason Kolbert and Jason McCarthy offer their thoughts:
Medivation reports tonight at 4:30pm…
We expect the focus to be on the recent proposals from Sanofi (SNY $38.75- NR); Pfizer (PFE $33.40 -NR), AstraZeneca (AZN $28.26-NR) and just today, Amgen (AMGN – $154.18 – NR)…
Medivation is returning to new highs as suitors line up to make acquisition bids. In this scenario what is the right discount rate for modeling purposes?
We believe our model for Xtandi revenues is good, therefore we review our risk rating and determine the following: 30% = $47 15% = $76 10% = $99
With Medivation’s board having now said No to anything less than $65 per share, it suggests to us that the stability and predictability of Xtandi’s revenues is greater than we thought, the risk is lower. Our intermediate risk rating is 15% or $76 fair value.
Shares of Medivation rose 0.3% to $59.22 today, while Pfizer gained 0.5% to $33.56, Sanofi fell 0.5% to $39.07, AstraZeneca dropped 0.6% to $39.07, Novartis declined 0.3% to $74.12, and Amgen ticked up 0.1% to $154.25.
- [By Ben Levisohn]
Last night, Bloomberg reported that Sanofi (SNY) had made a bid for Medivation (MDVN) but had been rebuffed, while noting that other companies–perhaps Gilead Sciences (GILD), Amgen (AMGN) or AstraZeneca (AZN)?–were also on the prowl. SunTrust Robinson Humphrey’s Peter Lawson explains why Medivation might be biotech’s most wanted:
- [By Ben Levisohn]
Macro considerations have continued to weigh on stocks whenever they’ve shown signs of life and consensus estimates for many of the large cap companies have been declining. With the sector’s underperformance, the delta in the average PEG ratio for biotech growth companies (excluding Medivation (MDVN)) compared to non-biotech growth companies is slightly wider than it’s been for most of the year. As such, we remain constructive on the sector. That said, while valuations are attractive on a relative basis, there remains some uncertainty for the group and we would not be surprised to see the volatility continue…
