Subscribe

Recent Articles

Popular Posts

Site search

Follow Us

Tag: Mercury News

Gilead Sciences to Buy CV Therapeutics for $1.4 Billion

Written by on Sunday, March 15th, 2009

Gilead Sciences has agreed to buy Palo Alto-based CV Therapeutics for $1.4 billion dollars.

According to SF Gate, Gilead Sciences will pay $20 per share for CV Therapeutics, which reported $154.5 million in revenue in 2008.  Most of that revenue comes from Ranexa, a drug from chronic angina.

Is this a good deal for Gilead Sciences?

Well, SF Gate reported that a Citi investment research analyst backed the deal as making "strategic sense" but described the price as "very steep."

The Mercury News explained the purchase as part of an overall Gilead strategy to acquire other companies and product lines in order to bolster their pipeline, which has been historically focused on HIV drugs.  The Mercury News reported:

[T]he company primarily owes its commercial success to its HIV drugs — Viread, Emtriva, Truvada and Atripla — which won FDA approval respectively in 2001, 2003, 2004 and 2006.Those drugs dominate the HIV-drug market and provide the vast majority of Gilead’s revenue, which totaled $5.34 billion in 2008, a 26 percent increase from 2007. On the basis of those sales, Gilead is the world’s third-biggest biotech company, behind Amgen of Thousand Oaks and Genentech of South San Francisco, according to data compiled by investment bank Jefferies & Co.To stay profitable, Gilead has been eager to branch out.

Some commentators, however, have suggested that the real value to this deal for Gilead Sciences is not so much the CV Therapeutics pipeline as it is the CV Therapeutics sales force. 

The In Vivo Blog reported as follows:

[Gilead] has also built a budding cardiovascular franchise centered around its pulmonary arterial hypertension drug Letairis and a Phase III drug for resistant hypertension called daruesentan. There’s a strategic fit argument, therefore, when it comes to Gilead’s buying CVT: the Palo Alto-based biotech provides the company with some additional diversification in a bulked up cardiology franchise–CVT already markets Ranexa and Lexiscan–as well as a ready-made sales force to market the products.

According to In Vivo Blog, there is the potential, however, for one additional Gilead benefit to doing this deal: full ownership rights in Lexiscan may eventually revert to CV Therapeutics, pending the outcome of litigation with Astellas.  if Gilead were to obtain full rights in Lexiscan, In Vivo Blog anticipates that this would be a real boost to Gilead’s bottom line. 

All in all, the consensus seems to be that Gilead took a bit of a financial risk in going forward with this deal, but that the risk is a reasonable one, which is in line with Gilead’s overall business strategy.  In the end, however, only time will tell if the move truly pays off for Gilead.

1,574 total views, no views today


Category: Biotech Deals  |  Comments Off on Gilead Sciences to Buy CV Therapeutics for $1.4 Billion

Court Ruling Denies Terminally Ill Patients the Right to Unapproved But Potentially Life-Saving Drugs

Written by on Thursday, August 9th, 2007

The U.S. Appeals Court in D.C. has ruled in an 8-2 decision that the terminally ill have no right to take unapproved drugs, even when their doctor says it is their best hope for survival.

The Mercury News reported on the decision as follows:

[T]he court said federal drug regulators are entrusted by law with deciding when new drugs are safe for wide use.

The families of terminally ill patients, several of whom died after they were denied promising drugs that were still in tests, filed the lawsuit. They said that dying patients were far more willing to take risks and argued that they should not be forced to wait for new treatments to win final approval from the Food and Drug Administration.

The judges said the families should take their pleas to Congress, not the courts.

However, the two dissenters said the ruling ignored the Constitution’s protection for individuals and their “right to life” and instead bowed to “a dangerous brand of paternalism” that put the government’s interests first.

According the The Mercury News, the next step is going to be to take this case to the Supreme Court.  It goes without saying that this is not likely to be the last we are hearing on this issue.

I have not seen a copy of the decision yet, so I’m interested to see how the majority reached the decision that they did.  My best guess without reading the decision is that the Court felt that this is a policy issue that should be decided by Congress, which seems to be what was reported above.

Clearly, from a pure policy perspective, the denial of access to potentially life-saving drugs to the terminally ill does not seem to be sound policy.   While the guinea pig argument (i.e. we want to protect the dying from being guinea pigs to be experimented on in their last days) may sound compelling to some, the reality is that most doctors are not going to do that to their patients.  They are only going to recommend possible treatments that hold some hope of working.  And why shouldn’t a patient who chooses to take a chance on an unapproved drug have that opportunity?  What is likelihood that any patient will really face a fate worse than what they are already going to face?

DrugWonks voiced a similar opinion today on the outcome of this case:

I believe the Abigail Alliance and others can make the case that they are not asking for wide use but targeted, tailored and scientifically responsible use that is consistent with their constitutional rights under the Fifth Amendment. This notion that somehow such rights are trumped by Padzur’s effort [to] take a wrecking ball to accelerated approval is a joke. The FDA is inconsistent on who gets what and when with respect to access to medicines and I don’t think the Supreme Court is going to let this “wide use” nonsense pass particularly since the Alliance is not asking for patients to determine when a product is safe but only to have the FDA create a regulatory pathway for allowing dying patients access.

It will be interesting to see what the Supreme Court says on this case, if it is indeed heard by the Court.  As those of us who have studied Constitution Law know, the concept of “rights” has been liberally interpreted on occasion, according to Constitutional scholars, to reach a particular result that seems “just” from a policy perspective.  Could the current Court do the same?

I somehow doubt it.  We have a “conservative” Court in place right now, so I doubt this Court will be reading new rights into the Constitution.  Granted, I am not a Constitutional Scholar, but that is my take on the current Court.

So, it’s quite possible that this will ultimately be placed in the lap of Congress, which will hopefully do the right thing and change the current policy.  There should be some way to legally access unapproved drugs in this country that might save your life when you are dying.  If someone wants to continue to fight to live until the bitter end and not throw in the towel, even if that person is grasping at straws, why should the FDA have the right to deny him or her that chance?  Who is the FDA really protecting in such a case?

680 total views, no views today


Category: Biotech Industry News, Biotech Legal Disputes  |  Comments Off on Court Ruling Denies Terminally Ill Patients the Right to Unapproved But Potentially Life-Saving Drugs

USPTO to reconsider Patents on HIV Drug Viread

Written by on Thursday, July 19th, 2007

The United States Patent and Trademark Office (“USPTO”) has agreed to reconsider patents on Gilead’s HIV drug Viread, according to a report by The Mercury News.

The Mercury News reported:

The Public Patent Foundation, a consumer advocacy group, claimed in a petition filed with the agency in March that the patents shouldn’t have been issued because key facts about the makeup of Viread – generically dubbed tenofovir – had been made public previously. . . .

Invalidating the patents would let other companies seek federal permission to sell the same drug, which could make Viread more widely available and lower its price, said Daniel Ravicher, the foundation’s executive director. Retail prices for drugs vary, but a 30-day supply of Viread can easily cost more than $1,000.

Viread sales were nearly $690 million in 2006, so it goes without saying that the invalidation of these patents could potentially be very costly for Gilead.  Moreover, Viread is a key component of two other Gilead drugs, Truvada and Atripla.  Thus, the invalidation of the patents could potentially impact the sales of those drugs as well.

Should Gilead be concerned?  The USPTO agrees to reconsider a large number of patents each year and only a small percentage of those patents are actually invalidated, so the odds of these patents being invalidated are probably relatively small.  Still, Gilead has to have some concerns, since the invalidation of these patents is likely to have a very real impact on the company’s bottom line.

816 total views, no views today


Category: Biotech Patents  |  Comments Off on USPTO to reconsider Patents on HIV Drug Viread

California Biotech Companies Rally Behind Proposed New Tax Legislation

Written by on Saturday, July 7th, 2007

California biotech companies are rallying behind proposed new state legislation, which would extend the time period that biotech companies have for claiming a tax deduction based on net operating losses.

The Mercury News reports:

The business leaders say their companies often labor for 15 years or more at a cost of hundreds of millions of dollars before they can get a drug approved for sale and generate enough revenue to climb out of the red. Yet under California law, they typically have only 10 years to claim a tax deduction based on their net operating losses.

Consequently, by the time they earn enough to pay state income taxes, many of them have lost the opportunity to claim the deduction. .  . .

That’s why [Assemblywoman Sally] Lieber has introduced a bill to double that deduction period, mirroring federal law. The measure, AB1370, which specifically gives biopharmaceutical businesses 20 years to claim their tax credits, was unanimously approved by the Assembly on June 6.

If it becomes law, it could give the biotech industry a big boost, according to Matthew Gardner, president of BayBio, an industry trade group based in South San Francisco.

While similar measures have failed twice before, supporters claim that this time is different, as there is more biotech support within assembly than existed in the past.  Three states–Florida, Illinois, and New York–already have a law on the books similar to this one being considered.

According to The Mercury News, this bills is not  the only way in which states are attempting to establish tax breaks for biotech companies:

Some[states] – including New Jersey and Hawaii – allow the firms to sell or trade their net operating loss credits to other businesses.

The article raises an interesting issue regarding tax deductions.  Is the bill a good idea for California’s taxpayers, or does it mean that we just have to bear more of the state’s tax burdens?

895 total views, no views today


Category: Biotech Legislative Developments  |  Comments Off on California Biotech Companies Rally Behind Proposed New Tax Legislation

© 2008-2015 The Prinz Law Office. All rights reserved.

The Prinz Law Office | Silicon Valley, CA | Los Angeles, CA | Orange County, CA | San Diego, CA | Atlanta, GA | Tel: 1.800.884.2124

Mailing Address: 117 Bernal Rd., Suite 70-110, San Jose, CA 95119; Silicon Valley Office: San Jose- 2033 Gateway Place, 5th Floor, San Jose, CA 95110 (408)884-2854; Los Angeles Office: 3110 Main St., Building C, Santa Monica, CA 90405 (310)907-9218; Orange County Office: 100 Spectrum Center Drive, 9th Floor, Irvine, CA 92618 (949)236-6777; San Diego Office: 4455 Murphy Canyon Road, Suite 100, San Diego, CA 92123 (619)354-2727 Atlanta Office: 1000 Parkwood Circle, Suite 900, Atlanta, Georgia 30339 (404)479-2470

Biotech Lawyer & Attorney: Serving Silicon Valley, San Jose, San Francisco, Santa Cruz, San Diego, Los Angeles, Orange County, Irvine, Anaheim, Santa Monica, Silicon Beach, Santa Barbara, Sacramento, Atlanta. Licensed in California and Georgia.
Follow

Get every new post delivered to your Inbox

Join other followers