Biotech and Medical Venture Deals Roundup
by Adam Rubenstein
OnBioVC
Tragara (San Diego, CA) a pharmaceutical company developing therapies for the treatment of lung cancer and inflammatory diseases closed a $40M Series A round. The financing was led by Domain Associates, ProQuest Investments, Morgenthaler Ventures, Oxford Bioscience Partners and Mitsubishi International Corporation.
Sanarus Medical (Pleasanton, CA) provides minimally invasive products for the diagnosis and treatment of breast tumors closed a $15M Series E round. The deal was led by Easton Capital Partners and Mosaix Ventures and were joined by U.S. Venture Partners, Forward Ventures, Alta Partners, Federated Kaufmann Fund, Pequot Ventures, Industry Ventures and Channel Medical Partners.
ProteoGenix (Portland, OR) a diagnostics company utilizing high-throughput protein analysis techniques to identify protein biomarkers for pregnancy-related complications closed a $20M Series B round. The financing was led by New Leaf Venture Partners, TPG Growth and Burrill and Company.
Epiphany Biosciences (San Francisco, CA) is developing both therapeutic products and diagnostic technologies that treat or prevent the spread of pathogenic viruses a new with its lead product for the treatment of Shingles closed a $36M Series A. The round was led by Wexford Capital other participants included Windsor Bay Capital, Global Trust Ventures Management and CDIB BioScience Venture Management.
Phenomix (San Diego, Calif.) a drug discovery and development company focused on the treatment of Type 2 diabetes and hepatitis C raised a $55M Series C financing. The deal was led by Nomura Phase4 and joined by JPMorgan, Delphi Ventures, Baker Brothers, Alta Partners, Sofinnova Ventures, Bay City Capital, CMEA Ventures, Novartis Venture Fund and GBS Venture Partners.
Spaltudaq (Seattle, WA) is focused on developing tumor-specific therapeutic antibodies for the treatment of cancer and infectious disease raised $29M in a Series B financing. The round was led by Arch Venture Partners and was joined by Canaan Partners, Healthcare Ventures, Amgen Ventures, MPM Capital and Alexandria Equities.
VentiRx Pharmaceuticals (Seattle, WA) a biopharmaceutical company focused on the development of medicines for the treatment of cancer and infectious, respiratory and autoimmune diseases, raised a $26.6M Series A round. The deal was led by Frazier Healthcare Ventures, ARCH Venture Partners and Domain Associates.
Transoma Medical (St. Paul, MN) maker of implantable wireless monitoring systems for patients with chronic cardiovascular disease closed a $13M Series C financing. The deal was led by Canaan Partners, Affinity Capital Management and Polaris Venture Partners.
PainCeptor (Canada) a drug company focused on the treatment of chronic and acute pain raised a $20.8M Series B round. The deal was lead by Desjardins Venture Capital, CDP Capital, T2C2 Capital, Business Development Bank of Canada and Lothian Partners.
Intarcia Therapeutics (Emeryville, CA) a biopharmaceutical company developing therapies for Type 2 Diabetes and Hepatitis C raised $50M in a Series BB Financing. The round was led by New Leaf Venture, and joined by Quilvest Ventures, New Enterprise Associates, Venrock Associates, Alta Partners, Omega Fund, and Granite Global Ventures.
TransOral Pharmaceuticals (Point Richmond, CA) a specialty pharmaceutical company CNS platform targeting insomnia and alcohol dependence, closed a $40M Series D financing. The deal was led by New Enterprise Associates additional participants included New Leaf Venture Partners, Montreux Equity Partners, InterWest Partners, Hamilton BioVentures, Vivo Ventures and Peninsula Equity Partners.
Tirus Therapeutics (San Diego, CA) a biopharmaceutical company developing next generation antibacterial drugs closed a $20M Series A round. The deal was led by Sofinnova Ventures and joined by InterWest Partners, Prism VentureWorks and Versant Ventures.
PneumRx (Mountain View, CA) a medical device company providing steerable biopsy needle devices to enhance lesion targeting and sampling, raised $27M Series B funding. The round was led by Adams Street Partners and Telegraph Hill Partners additional participants included Sage Venture Partners, Alta Partners, KBL Healthcare Ventures and Spray Venture Partners.
RegImmune (Mountain View, CA) technology platform named reVax is targeting various allergic and immune diseases, with lead indications in allergies and organ rejection has raised a $4.2M Series B round. The deal was lead by NIF SMBC Ventures Co. Ltd. and was joined by Japan Asia Investment Co. Ltd., JAFCO Co. Ltd., Orix Capital Corporation, Yasuda Enterprise Development Co. Ltd., New Business Investment Co. Ltd., Mitsubishi UFJ Capital Co. Ltd., and Fund Creation Co. Ltd.
Calistoga Pharmaceuticals (Seattle, WA) a drug development startup focused on oncology and inflammation raised a $21M Series A. The deal was led by Frazier Healthcare Ventures and was joined by Alta Partners, Three Arch Partners and Amgen Ventures.
CoDa Therapeutics (New Zeland) -based drug company focused on Nexagon, a wound care and tissue repair therapeutic, raised a $20M Series A financing. The round was led by Domain Associates and GBS Venture Partners.
Source: OnBioVC.com
PREVIOUS VENTURE DEAL ROUNDUPS:
- March 24, 2007
- March 10, 2007
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IBD Weekly Top Ranked Medical Stocks
The following list represents the top ten medical stocks ranked according to Earnings Per Share and Relative Strength by Investor’s Business Daily (3/31/07)
scores out of 100 (last week’s rank, change in score):
1(3) Medtox Scientific (MTOX) EPS=99 RS=96(+2)
2(1) Rochester Medical (ROCM) EPS=95 RS=99
3(2) Cynosure (CYNO) EPS=96 RS=98(+1)
4(4) Wellcare (WCG) EPS=97 RS=96
5(5) Arrhythmia Research (HRT) EPS=94 RS=98(+1)
6(6) LHC Group (LHCG) EPS=98 RS=92(+4)
7(8) Icon PLC (ICLR) EPS=93 RS=93(+1)
8(10) Almosts Family (AFAM) EPS=86 RS=98
9(-) Omrix Biopharmaceuticals (OMRI) EPS=84 RS=99
10(9) Emdeon (HLTH) EPS=99 RS=84(-1)
- Mar 24; IBD Weekly Top Ranked Medical Stocks
- Mar 17; IBD Weekly Top Ranked Medical Stocks
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Biotech Daily Review: Novartis Pulls Zelnorm Off The Market
by Richard Daverman, PhD
Centient Biotech Investor
Novartis (NVS) suspended sales of Zelnorm, a treatment for irritable bowel syndrome with constipation, at the request of the FDA. The agency noticed a statistically significant number of cases of angina pectoris in patients taking the drug. Zelnorm has been approved since 2002. The news took a 4% bite out of Novartis, which fell $2.26 to $54.63.
An FDA advisory panel recommended approval for Provenge, the cancer vaccine from Dendreon (DNDN). In its Phase III trial, Provenge did not meet its primary endpoint of extending the time-to-progression in prostate cancer patients, but it did increase median survival by a median 4.5 months to 25.9 months. The vote of the panel was 13-4 in favor of approving the drug. The drug was given to patients whose prostate cancer was not responding to hormone therapy. The FDA will render its decision on Provenge on May 15. Because the news was not widely expected, Dendreon soared. After trading as high as $18, Dendreon ended the day at $12.93, a gain of $7.71 or 148%.
Vivus (VVUS) sold the rights to EvaMist, a transdermal estradiol spray for menopause, to KV Therapeutics. EvaMist is currently awaiting an FDA final marketing decision, which is expected July 29, 2007. KV will pay $10 million upfront and $140 million if the drug is approved. Another $30 million is available for sales milestones. The spray delivery device contains a meter that measures the amount of estradiol that is delivered. Vivus was 40 cents higher at $5.13.
Progenics (PGNX) and Wyeth (WYE) asked the FDA to approve their treatment for opioid-induced constipation. Methylnaltrexone is aimed at treating OIC without interfering with the pain relief that opioids produce. If the drug is approved, Wyeth will own the worldwide rights, while Progenics has the option of co-promoting the drug in the US. Progenics was up 4 cents at $23.68, and Wyeth added on 13 cents to close at $50.03.
Wyeth also reported that bifeprunox improved symptoms in patients with acute exacerbations of schizophrenia, while maintaining stability is patients with stable disease. Also the drug did not increase weight or lipid levels, as other treatments are prone to do. The drug is under review at the FDA.
Astellas Pharma of Japan will pay up to $120 million for a non-exclusive license to the VelocImmune technology developed by Regeneron (REGN). Astellas paid $20 million upfront, and it will make up to five additional $20 million payments in the next five years. The technology is used to discover human monoclonal antibody product candidates. Regeneron moved up 37 cents to $21.62.
Galapagos NV received 3.2 million euros in milestones from GlaxoSmithKline (GSK) in their osteoarthritis partnership. The partnership attained two milestones in their collaboration, which began in June 2006. Galapagos is responsible for identifying molecules and developing them through Phase IIa trials. At that point, GSK has the option of doing the rest of the development work.
GlaxoSmithKline also submitted its Biologics License Application to the FDA for Cervarix, its vaccine for human papillomavirus which causes cervical cancer. GlaxoSmithKline climbed 71 cents to $55.26.
Quark Biotech (QURK) filed to raise $86 million in its IPO. Quark, a company that uses gene silencing mechanisms in its drugs, has out-licensed a drug for wet age-related macular degeneration to Pfizer (PFE). The drug, which is in Phase I/II trials, uses a different mechanism than the anti-VEGF drugs currently approved for wet AMG. Quark has a second drug that is about to start a Phase I trial for acute renal failure.
NovaCardia (NCAR), a company focused on treatments for cardiovascular diseases, will seek to raise $86 million in its IPO. It has a drug for congestive heart failure that has completed three Phase II trials and a Phase III test. NovaCardia also has an atrial fibrillation drug that will soon begin a Phase II study.
Biotech booked a decent gain in the last session of the week. The Centient Biotech 200™ rose 15 points to 3879, an increase of .40%. The S&P 500 was down .12% in today’s session, but Nasdaq was higher by .16%.
Source: CentientInvestor.com
RELATED READING:
- Biotech Daily Review: CuraGen Gets $155M For Gene Sequence Division
- Biotech Daily Review: Sanofi-Aventis Lands Cancer Vaccine For $680M
- Biotech Daily Review: Regeneron Up On AMD Data
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Federal Circuit Allows Declaratory Judgment Jurisdiction for Generic Drug Patent Challenges
by Aaron F. Barkoff
Orange Book Blog
Teva Pharms. USA v. Novartis Pharms. et al., No. 06-1181 (Fed. Cir. 2007)
For the second time in as many days, the Federal Circuit has decided a case with broad implications for innovator and generic drug companies. The decision today, in Teva (TEVA) v. Novartis (NVS), opens the door to many more lawsuits by generic drug companies seeking declarations of patent invalidity or noninfringement.
The Federal Circuit held as follows:
A justiciable declaratory judgment controversy arises for an ANDA filer when a patentee lists patents in the Orange Book, the ANDA applicant files its ANDA certifying the listed patents under paragraph IV, and the patentee brings an action against the submitted ANDA on one or more of the patents. The combination of these three circumstances is dispositive in establishing an actual declaratory judgment controversy as to all the paragraph IV certified patents, whether the patentee has sued on all or only some of the paragraph IV certified patents.
In the case, Teva filed an ANDA to market a generic version of Famvir, an antiviral medication. Novartis then sued Teva for infringing U.S. Patent No. 5,246,937, which covers the active ingredient in Famvir, famciclovir. Novartis chose not to sue Teva on any of its other four Orange Book-listed patents for Famvir, each of which covers methods of use. Teva then brought a declaratory judgment action on the four remaining method patents under a provision of the 2003 Medicare Modernization Act entitled “civil action to obtain patent certainty.” The district court dismissed Teva’s complaint, and the Federal Circuit has now reversed the dismissal.
The district court dismissed the case pursuant to the Federal Circuit’s application of its “reasonable apprehension of suit” test in Teva v. Pfizer (PFE). However, the Supreme Court’s recent decision in MedImmune has forced the Federal Circuit to revisit that test. Indeed, in today’s opinion the Federal Circuit expressly acknowledged that MedImmune overruled the “reasonable apprehension of suit” test.
Today’s decision removes an important weapon innovator drug companies had in their battle against generics: the uncertainty and risk faced by generics when deciding whether to launch their generic drug products before patent expiration. Now, generics in Teva’s position will be able to file a declaratory judgment action and obtain a court decision on the validity or infringement of Orange Book-listed patents before deciding whether to launch. In fact, the Federal Circuit’s decision today suggests that unless an innovator grants a covenant not to sue, the innovator’s listing of a patent in the Orange Book coupled with a generic’s paragraph IV certification may be sufficient to establish declaratory judgment jurisdiction.
Source: OrangeBookBlog.com
RELATED READING:
- Feb. 26 OBB post on this case
- Jan. 31 OBB post on a DJ case recently filed by Apotex
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Will Dendreon’s Cancer Vaccine Win Final FDA Approval?
by Richard Daverman, PhD
Centient Biotech Investor
In a surprise move, a FDA advisory committee yesterday recommended approval of the cancer immunotherapy Provenge from Dendreon (DNDN). The drug treats prostate cancer, but it missed its endpoint in a Phase III trial, which was to extend the time-to-progression in prostate cancer patients whose disease did not respond to hormone therapy.
A subsequent analysis showed that the drug extended median survival by 4.5 months, raising it to 25.9 months from 21.4 months. The result was statistically significant, though the trial, which enrolled just 127 patients, was small. In an even smaller trial, the median survival increased only 3 months, missing the level of statistical significance.
Currently, Dendreon has Provenge in a larger trial, involving 500 patients, which is due to finish in 2010.
The news of the FDA recommendation had a powerful effect on the shares of Dendreon. They opened with a clear triple at $18. The stock closed Wednesday at $5.22 (it did not trade on Thursday while the FDA was discussing the drug). After an hour of trading, Dendreon was still up 166% at $13.85, a gain of $8.63. The news also had a positive effect on Cell Genesys (CEGE), which is developing a competitor immunotherapy for prostate cancer with Medarex (MEDX). Cell Genesys was 21% higher, rising 74 cents to $4.24.
The panel voted 13-4 in favor of considering Provenge effective. The tally was 17-0 in favor of calling Provenge safe. There is some worry that the drug causes strokes, but that hasn’t been proven. The only current competitor to Provenge is the chemotherapy taxotere, which does cause side effects. The FDA is scheduled to release its final opinion on Provenge on May 15. Usually, the agency follows the advice of the Advisory committee.
The FDA could, conceivably, wait until 2010 to see more data before approving the drug.
In the Provenge treatment, a portion of the patient’s white blood cells are removed and sent to Dendreon. The cells are mixed with a genetically engineered protein that combines an immune system booster and a molecule found in prostate cancer cells but nowhere else. The idea is to make the patient’s own immune system fight the cancer, which is why the treatment is called a vaccine.
Immunotherapy treatments for cancer have been tried before. No one knows why the immune system does not recognize the cancer cells as foreign and fight to eradicate them from the body. But until now, the treatments have not been able to prove that they helped.
Source: CentientInvestor.com
RELATED READING:
- Dendreon: Massive Pre-Market Action
- Dendreon Conference Call Transcript Summary & Commentary
- Dendreon’s Big Day: Favorable FDA Review, Wild Trading Day Tomorrow
- Dendreon’s Last Day Ahead of FDA
- Dendreon: A Make or Break Week
- Dendreon: Trading Strategy Ahead of FDA Review
- Dendreon Interest Remains; Early Volume Surges
- Dendreon’s Stock Activity Ahead of FDA Review
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Friday’s Top Biotech & Medical Stocks
by H.S. Ayoub
BioHealth Investor.com
Biotechnology
DENDREON CORP [DNDN] +147.70%
CELL GENESYS INC [CEGE] +20.00%
FAVRILLE, INC. [FVRL] +17.18%
ADVENTRX PHARMACTL [ANX] +13.64%
ANTIGENICS INC [AGEN] +12.63%
Diagnostic Substances
ICAGEN, INC. [ICGN] +6.62%
SONUS PHARM INC [SNUS] +5.01%
PRESSURE BIOSCIENC [PBIO] +4.69%
TORREYPINES THERAPEU [TPTX] +4.50%
MONOGRAM BIOSCIENCES [MGRM] +3.19%
Drug Delivery
IOMED INC [IOX] +11.73%
SKYEPHARMA PLC [SKYE] +5.29%
NEKTAR THERAPEUTIC [NKTR] +4.06%
DELCATH SYSTEMS INC [DCTH] +3.61%
COLUMBIA LABS INC [CBRX] +3.08%
Drug Manufacturers
YM BIOSCIENCES INC [YMI] +31.76%
PROTALEX INC [PRTX.OB] +11.43%
AVI BIOPHARMA INC [AVII] +11.20%
NEXMED INC [NEXM] +10.71%
SCICLONE PHARMA [SCLN] +9.59%
Drug Related Products
XELR8 HOLDINGS, INC [BZI] +5.13%
MEDICAL NUTRITN USA [MDNU.OB] +2.38%
DRAXIS HEALTH INC [DRAX] +2.05%
MANNATECH INC [MTEX] +1.97%
PERRIGO COMPANY [PRGO] +1.61%
Generic Drugs
ISOLAGEN INC [ILE] +4.24%
HI-TECH PHARMACAL [HITK] +2.39%
CARACO PHARMA LABS [CPD] +0.74%
MYLAN LABS INC [MYL] +0.62%
CATALYST PHARMACEUTI [CPRX] +0.25%
Medical Appliances & Equipment
PHOTOMEDEX INC [PHMD] +13.33%
NON INVASIVE MONITORNG SYS NEW [NIMU.OB] +12.73%
ENDOCARE INC [ENDO.OB] +8.82%
MICROTEK MED HLDGS [MTMD] +8.18%
THERAGENICS CORP [TGX] +7.01%
Medical Instruments & Supplies
LEMAITRE VASCULAR [LMAT] +8.50%
VIVUS INC [VVUS] +8.46%
ANTARES PHARMA INC [AIS] +8.39%
MILESTONE SCIENTIFIC [MLSS.OB] +8.16%
STRATEGIC DIAGNOST [SDIX] +7.56%
Medical Laboratories & Research
MEDTOX SCIENTFIC INC [MTOX] +8.53%
NEOGENOMICS INC [NGNM.OB] +5.77%
SPHERIX INC [SPEX] +4.72%
BIO-IMAGING TECH [BITI] +2.96%
ALLIANCE IMAGING INC [AIQ] +1.99%
- Thursday’s Top Biotech and Medical Stocks
- Wednesday’s Top Biotech and Medical Stocks
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Alexion Takes Rising Healthcare Costs to Next Level!
by Chard Brand
Peridot Capitalist
LOS ANGELES, March 26 (Reuters) - Shares of Alexion Pharmaceuticals Inc. (ALXN) rose more than 9 percent on Monday after the company told analysts that its treatment for a rare blood disorder would be priced at $389,000 per year.
The drug, Soliris, was approved earlier this month as the first product to treat paroxysmal nocturnal hemoglobinuria (PNH), a condition that affects fewer than 200,000 people in the United States.
“We considered many factors when establishing a price for Soliris. These included the rarity of this disabling and life threatening disease, the compelling clinical benefits that PNH patients experience with Soliris … the cost of discovery, development and production, and of ongoing research …,” David Keiser, the chief operating officer said on the call.
The company’s shares rose $3.71 to close at $43.78 on Nasdaq.
Imagine you are one of those approximately 200,000 people in the U.S. who have PNH. Finally, a drug has been approved by the FDA that may help you tremendously. You would likely be exuberant, for a little while anyway, until you learned how much the drug will cost. And that price is at the wholesale level.
This isn’t a political blog, so I’m not going to get into a discussion about what our country should do about healthcare costs that are spiraling out of control. No matter your view on the subject, investors should realize that until something changes, until a drug that is the first one approved to treat a condition doesn’t cost $389,000 per year, healthcare companies are probably going to have an easy time making money.
Some people won’t care, some people will be outraged and refuse to buy a stock like Alexion, and others will be outraged but will also separate their inner beliefs and politics from their investment strategy for the sake of reaching their financial goals. I have no opinion on the investment merit of Alexion stock, as I haven’t done work on it. It’s no shock though that it reacted well to this news.
Source: PeridotCapitalist.com
RELATED READING:
- High Cost of New Cancer Drugs Force Government Intervention
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Dendreon: Massive Pre-Market Action
by Jon C. Ogg
24/7 Wall St.
Dendreon (DNDN) won big yesterday after receiving panel backing from the FDA for Provenge for the treatment of advanced prostate cancer. The stock has reopened for trading just a few minutes ago and the prints are amazing. The prints have been all over the place, but as of 7:15 AM EST after it has been open for a few minutes the stock has shown more than a 200% rise. Shares closed Wednesday at $5.22 and were halted all day yesterday. The prints look to be around $16.00 but there looked like tehre were prints as low as $13.00 and as high as $18.00+.
Who knows exactly where this one will be by the open, but part of the reason for the meteoric rise outside of the news itself is the short sellers and the options traders. The open interest in the April and May option contracts was more than 300,000 contracts on a net basis and the March short interest grew to more than 26.4 million shares versus 20.3 million shares in February (so now more than 32.4% of the float). Needless to say, there are some short sellers getting kicked in the shorts this morning.
You can see a summary of the transcript of the conference call the company gave last night here with the Q&A from analysts.
Source: 247WallSt.com
RELATED READING:
- Dendreon Conference Call Transcript Summary & Commentary
- Dendreon’s Big Day: Favorable FDA Review, Wild Trading Day Tomorrow
- Dendreon’s Last Day Ahead of FDA
- Dendreon: A Make or Break Week
- Dendreon: Trading Strategy Ahead of FDA Review
- Dendreon Interest Remains; Early Volume Surges
- Dendreon’s Stock Activity Ahead of FDA Review
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Dendreon Conference Call Transcript Summary & Commentary
by Jon C. Ogg
24/7 Wall St.
Dendreon (DNDN) spoke on a planned conference call this evening that was moved to 6:30 PM EST rather than the 7:30 PM EST planned time. They probably had a major steak dinner and 12 cases of champagne to get to. I know I would if I was them. This was on the favorable outcome out of the FDA Panel Review for its Provenge(R) for the late stage patients suffering from advanced prostate cancer. The company noted the evidence of safety and efficacy, and Provenge will provide the treatment that extends survival t these patients. Dendreon says will be working with FDA and the PDUFA day is currently May 15. Please pardon the lack of names because it was hard to tell who was speaking inside the company to analysts.
We note here the name of the firm asking the question, and then we have noted the questions with the answers. This was taken in notation format since it was a summary, so you will have to see the “question” or “ask” and then get the answer that follows it. Here goes:
JMP Securities analyst: As far as commercial plans and launch here and abroad?
The company said that they can launch it themselves here. They expect a decision by May 15 PDUFA date and will go from there. The other study is 400 patients enrolled. As far as looking at this in models for number of patients???? The company noted it is 98,600 men and there are 50,00 in the target in the US; in Europe they think it is similar but it isn’t known in Asia. As far as “additional data submissions” on manufacturing???? They had the FDA inspect the facilities and they are still being discussed before PDUFA date. Analyst admitted he had some champagne, funny and then asked about sales force: the company said they can handle 125 individuals and they can manage it.
Biotech Stock Research (David Miller), newsletter writer that has been positive on DNDN: As far as when they are pulling the trigger, but they didn’t really say much. As far as giving thought to “FDA saying go ahead and marketing”?? They are completing the “IIb study” and are still discussing with the FDA. Is there a chance for a label of “for Caucasians only”? The co. says they are discussing that with the FDA but they don’t see a difference biologically in prostate cancer. Company says enrolling minorities had similar profile but admitted difficulties. On the Shelf Registration and Timing? The company said it is preliminary to talk specifics but they said as they get more feedback that they WILL require additional funds. (For conjecture, it was hard to tell if the company meant they would wait until the PDUFA date of May 15 before they announce a share sale or if they would do it sooner)
NEEDHAM Analyst: With 400 patients enrolled in the IIb, do they know when they will see more results? The company is maintaining again they will complete enrollment. The company would not predict the exact outcome, but the FDA has so far given the right indications and the patient community was clear in wanting a new treatment. As far as what the answers WILL and CAN be from FDA: company is pleased today but won’t predict the outcome. In New Jersey plant how many patients can they treat: they still don’t know until the FDA PDUFA.
Bank of America analyst: As far as panel members and association with politics inside FDA…company won’t comment there on politics inside FDA. (it sounded like company is working with the more favorable group, or so they inferred)
UBS analyst: As far as numbers of enrollments inside impact study seeming less than 200 in Provenge arm and 100 in placebo group? The co. said the actual number was 400 patients and that wasn’t shown in a slide. The will show 360 death events the estimate to show by or in 2010. The company won’t show a pre-specified look at IIb results.
Lazard substitute analyst: What is the risk that PDUFA date decision will be different because of different dates? Company said the wording was changed by FDA and any confusions were from the wording the FDA used. The company won’t speculate as far as certain outcome, but again said FDA usually follows its panel recommendation.
McAdams Wright Ragen analyst: On the FDA meeting being 8 hours long and an indication of what got them over the goal line to panel backing? Co. says the presenting team did a great job and they made this happen. The survival data carried the most weight AND the comments from the patient group made a huge difference. As far as FDA meetings ahead and guidance on cash burn? The company will update that as they know more. Question on whether investors should watch for most pertinent news out of the company or out of the FDA? The company says they will communicate the bulk of the data and they try to keep that up as they have been a constant communicator.
Lazard (main) analyst: As far as questions the panel asked in efficacies? The company said the first was 17-0 and the second was 13-4 and there may have been some difficulty in interpreting the question. Will the FDA ask additional questions or different questions? The company doesn’t know why they would but they won’t predict. On interim II study? The company will look at those and make them available when they have it.
The CEO said this was a historic day for prostate cancer patients and for the company. As far as our comment on this: “Yeah, you can say that again.”
CONJECTURE: As far as any conjecture on analyzing how the company did on their answers, this is fairly easy. I re-listened to the conference call to make sure on this, but all in all the company handled everything they could quite well. They were very straight and to the point on most of these, even though some of these answers were repetitive. There were not any classic tells shown of lying or highly selective omissions made by management. There is obviously not a riskless transaction, because there never is. But all in all it sure seems like the company and the community would seem to agree that this PDUFA date of May 15 will go in favor of the company. Is that an assurance? No way. The FDA does some strange things sometimes, and lately they seem more and more that way. Prostate cancer patients have more likely than not just made a new friend, and because of that there are some pretty happy investors today. Be sure to watch out for a secondary offering at some point, because while the company did put that off a bit they did say that they will need more cash to ramp everything up to proceed. And companies can change their stance quite rapidly, particularly if they get a massive jump in their stock prices. Watch out for this one tomorrow, because with the 200,000 to 300,000 of near months’ expirations (April & May) open interest and the massive short interest of more than 30% of the float this one is going to be wild Friday. Does window dressing matter for that day? Maybe. Dendreon (DNDN) shares did not reopen today, so the trading will resume Friday. There is a chance that you can track this on Friday much earlier than would normally be available because the stock does actually trade in Germany under the “DNR” ticker in Frankfurt, BUT you will have to verify all that data and pricing for accuracy since almost everyone in the U.S. has delayed quotes for Germany. OK, it’s been a 15 hour day on the desk, so good night….. and congratulations to Dendreon and to advanced prostate cancer patients hoping for one more possible treatment.
Source: 247WallSt.com
RELATED READING:
- Dendreon’s Big Day: Favorable FDA Review, Wild Trading Day Tomorrow
- Dendreon’s Last Day Ahead of FDA
- Dendreon: A Make or Break Week
- Dendreon: Trading Strategy Ahead of FDA Review
- Dendreon Interest Remains; Early Volume Surges
- Dendreon’s Stock Activity Ahead of FDA Review
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Merck Prevails in Patent Term Extension Case at Federal Circuit
by Aaron F. Barkoff
Orange Book Blog
The U.S. Court of Appeals for the Federal Circuit held today that a patent term extension under 35 USC 156 may be applied to a patent subject to a terminal disclaimer under 35 USC 253, handing a victory to Merck (MRK) in its battle with Hi-Tech Pharmacal over generic Trusopt (dorzolamide HCl opthalmic solution).
Section 156 was enacted as part of the Hatch-Waxman Act in 1984 to allow restoration of part of a pharmaceutical patent’s term “lost” due to lengthy FDA review of a new drug application. Section 253, on the other hand, applies to all kinds of patent applications–not only those relating to pharmaceuticals–and allows the filing of a terminal disclaimer to overcome “obviousness-type double patenting” rejections made by the Patent Office.
As we reported last month, a loss for Merck in this case would have had far-reaching effects on pharmaceutical companies and patent owners, since the Patent Office has routinely granted patent term extensions on patents that are subject to a terminal disclaimer. Brand-name drug companies would have lost years of patent protection on some of their best-selling drugs if the Federal Circuit had decided that a terminal disclaimer precludes a patent term extension.
In reaching its decision today, the Federal Circuit properly recognized that “the language of Section 156 is unambiguous and fulfills a purpose unrelated to and not in conflict with that of Section 253.”
Source: OrangeBookBlog.com
RELATED READING:
- MarketWatch.com
- Merck Pressured to Halt Gardasil Vaccine Lobbying
- Merck Wants Out of Pfizer’s Shadow
- Merck Putting Vioxx Behind It
- Merck Looking To Become RNAi Technology Leader
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