May 12 FDA ADCOM meeting to discus approval of Orakambi (809/770)
Non stop speculation about GILD making a bid for acquiring VRTX.
Early approval of Orakambi following ADCOM recommending approval
Pricing and commercial launch within days of FDA approval of Orakambi
PHASE 2B VX 787 influenza clinical trial data release starts to bring attention to non-CF assets in VRTX pipline and analysts add potential revenue/eps to their valuation models for these earlier stage drugs in the VRTX pipline e.g. oncology drugs as well as influenza in addition to CF franchise.
Advancement of second gen correctors to clinical trials to treat CF patients
initiation of clinical trials to treat neurologic disease e.g. Cervcial spine injury, HD and chronic MS.
GILD CEO discussed during today's first qtr CC being open to suggestions involving GILD acquiring a competing large pharma that would enhance revenue in a disease area GILD already has a presence in. Vertex growing leadership in the CF space fits perfectly. Porges probably has been lobbying hard to have his firm, Bernstein, assist GILD orchestrate a takeover bid. Will Vertex be forced to accept a hostile bid by shareholders? I doubt VRTX management would do so without resisting it strongly first. IMHO, should J&J Novartis or Pfizer be interested in acquiring VRTX as well, a bidding war would make a buy out of VRTX more likely.
Dr. Li part of the private equity group making the offer. He'll get paid at both ends. Former Goldman manager heads the private equity group. Interesting timing for offer considering GS removed WX from it's focus list, downgraded the company and lowered it's target price just a few months ago, driving WX share price to the low 30's at the time. I wonder who was buying up WX shares $10 cheaper a few months ago?
Low ball offer considering potential future growth for WX contract pharma business both in China and in the U.S. They will also be entering patent pharma business in China, a huge future growth market. Taking them private now is an opportunity for the private equity group to gather the shares back cheap and in a year or two reissue them in a new public offering at much higher value. Existing shareholders being shown the door after they took all the early risk when the company went public a few years back, with the private equity group now ready to buy the company relatively cheap as the company is about to transform itself into a major pharmaceutical company with much greater growth and earnings coming in the next few years.
I agree that historically VRTX has resisted buyout, but there is a price for everything if it's high enough, and a hostile takeover may be possible depending on the wishes of the institutional shareholders who would control the voting of such a merger. However, IMHO VRTX shareholders long term would do best if the company remains independent. If Geoff Porges, who a year ago said 809/770 was not going to be commercially successful, now says the company is worth $45 billion today on the strength of the very same CF drug and GILD acquiring VRTX at $180 per share would cause a rise in GILD share value, that of course implies that VRTX is worth a lot more than $180 per share or why would GILD bother to pay that price? So I hope VRTX does not get a take out offer and that it's entire pipeline is discussed this week at the conference call on April 29 to show the much greater growth potential that VRTX has coming from both it's CF and non CF assets.
AF from TSC wrote last year about Porges, the analyst from Bernstein a year ago, who was saying 809/770 won't work following the EU CF meeting and drove the share price of VRTX to the 64 dollar range. Now he writes that Porges values VRTX at least $180 per share on the strength of the very same CF drugs, and should be bought out by GILD for that price. (Of course once again giving little or no value to the rest of the VRTX pipeline). How come AF is not recalling in his article today the Porges comments from last year?
Apple wants a presence in personal health care with wearable health care monitoring, and DXCM share product already programmed for app to i-phone and i-watch. Good product synergy with lots of growth potential that could be be adopted by millions of diabetics worldwide. Google has similar aspirations with their android phone and google glass. Would either make a takeover offer?
Investors either anticipating better than expected 1st quarter revenues which will likely accelerate over the rest of this year, or perhaps takeover speculation over DXCM being acquired by a larger company wanting to own the leading CGM technology.
Week of April 29: Vertex first quarter conference call: Anticipate announcement of timeline of 809/770 approval process and marketing plan as well as expanded label of 770. Likely to comment on 661/770 development plans including 3 drug combination with second corrector to treat 508 heterozygotes, and anticipated timing of readout of 661/770 Phase 3 clinical trials data. Also may get comments on non-CF pipeline drug candidates e.g. clinical trial progress in influenza and oncology as well as clinical trials planned for treatment of neurologic disease (spinal cord injury, Huntingtons and chronic MS).
809/770 FDA ADCOM meeting May 12, 2015 with endorsement of FDA approval
FDA approval 809/770 anticipated shortly after May 12 meeting with pricing in the US announced shortly thereafter.
EU Annual CF meeting June 10-13 in Belgium. Vertex clinical trial data presentations to support approval of 809/770 outside the US and approval of the expanded use of 770 mono-therapy in non 551 gating mutations and residual function mutation patients and children ages 2-5 in in 551 and other responsive mutations
Bravo!! The CF community is lucky to have people like you, Verity, to fight for this important medication that will benefit so many lives. Your efforts will make a difference.
Verity, I understand your frustration. With Obama giving a shout out to the CF community during his State of the Union Speech in January, and having Bill Elder sitting next to the first lady in the gallery, you would think with the FDA,already designating 809/770 with 'breakthrough drug' status, it would expedite the approval process faster. Is the CF community and it's advocacy groups reaching out to their White House or Congressional connections to motivate the FDA to move the approval process along more efficiently, given the Phase 3 safety and efficacy data submitted by Vertex close to 6 months ago and allow the CF population this very important treatment?.
RBC Analyst remains confident of FDA approval before PDUFA date of July 5, following the May 12 meeting
Market pullback overdue. High-flying biotech/high tech company valuations having expected corrections. 809/770 approval and pricing will return VRTX to new 52 week highs.
IF VX 661/770 shows a 6% improvement in absolute FEV-1 treating twenty CF 508 homozygotes for twelve weeks, the market is going to tell you what insurance companies are likely to pay for such an improvement, (along with the likely associated reduction in hospitalizations and pulmonary infections, improved body weight and nutritional status, lengthened life expectancy and improvement in quality of life in the majority of CF patients), with the movement up in VRTX share price after the data is released, We'll soon find out the answer in the next few days. Good luck to all longs and to the CF community!
It would certainly be contested in federal court if the patent office ruled it a new entity. The court can over rule an initial patent office decision but often it requires a jury trial. Probably more cost effective for VRTX to buyout CNCE if D-Ivacaftor is a significant improvement over the original drug. That will take a few years to prove, and will be watched closely by VRTX management who know Roger Tung well from his years at VRTX.
If you look up the home page for EIP Pharma you'll get some background on the Connection of EIP, whose CEO is John Alam, MD, (oldtimers on this board may recall; he was a formrer CMO at Vertex prior to the development of telaprevir). Vertex has licensed VX 745 to EIP since 2012 and evidently is making some progress in applying it to treat inflammation in the CNS to see if it has any clinical benefit in neurologic diseases like Alzheimers. Vertex program to treat neurologic disease or injury has much greater depth and progress than most investors appreciate for spinal cord injury, Huntington's, chronic MS, pain, and Alzheimers . Thanks Rojo for this update.
Stock price moving to new highs today anticipating CF drug approvals with PDUFA for expanded pediatric label for Kalydeco due tomorrow, and earlier than anticipated 809/770 approval soon to follow........
FYI: a few of my other current medical science company investments: (Do your own due diligence before investing!)
MACK (Merrimack Pharmaceuticals) An oncology company with a it's first drug to be approved at the end of March or early April 2015..Large insider ownership with many shares recently purchased on the open market like the rest of us. Has a partnership with Baxter to market it's most advanced drug outside the U.S. Has a deep pipeline of other drugs that will change the paradigm for treating solid tumors on the molecular level, analogous to individualizing treatment of the various mutations of CF
DXCM (Dexcom) The leader in CGM (continuous glucose monitoring) in the treatment of Type 1 DM. Partnerships with insulin pump makers JNJ (Animus division) and Insulet, and working to eliminate the need for finger stick bloodsugar testing; Has apps to I-phone and Android smart phones allowing parents of pediatric patients, and caregivers monitoring of blood sugars to avoid highs and lows, preventing dangerous complications and hospitalizations. Collaborating it's technology to develop artificial pancreas closed loop insulin delivery system not requiring finger stick blood sugar testing. Just became profitable in the past quarter.
QDEL (Quidel Corp) I'm a fan. (hence my moniker). A leader in the point of care and molecular rapid diagnostics market. Has developed a whole new group of rapid POC (point of care diagnostics) that is starting to gain traction in sales for detection of multiple infections, Huge insider ownership and superb management. It's pipeline has a number of innovative new diagnostic platforms to test for multiple pathogens both quantitatively as well as qualitatively to monitor response to treatment of diseases like HIV.