Replies to post #75989 on Biotech Values

[DewDiligence]

I wonder how many people had heard of BiPar Sciences until now.

[DewDiligence]

Glaxo in Talks to Acquire Stiefel Labs

[GSK’s CEO, Andrew Witty, likes to talk about “bolt-on” acquisitions. This will be such a deal, if it goes through.]

http://online.wsj.com/article/SB124017856765232773.html

›APRIL 20, 2009
By DANA CIMILLUCA and JEANNE WHALEN

GlaxoSmithKline PLC is close to an agreement to acquire Stiefel Laboratories Inc. for about $3 billion, people familiar with the matter said, in a deal that continues a wave of acquisitions in the drug industry.

Closely held Stiefel, a U.S. maker of dermatology products, is part-owned by buyout firm Blackstone Group. An auction of the company drew interest from several major global drug companies, including Sanofi-Aventis SA, after Stiefel was put up for sale earlier this year.

The Glaxo deal is expected to be announced as soon as Monday. However, people close to the situation cautioned there is still a chance it could fall apart. It is the latest in a wave of takeovers among big pharmaceutical companies, which are looking for new sources of sales growth as some of their biggest drugs face competition from cheaper generics.

Stiefel products treat a wide range of skin ailments. The company makes treatments such as the DUAC acne gel and OLUX, an anti-itch foam for the scalp. The company has been controlled for more than 160 years by the founding Stiefel family. It has expanded in recent years through a string of acquisitions, including the roughly $600 million purchase of Connetics Corp. in 2006. Blackstone invested $500 million in Stiefel in 2007 for a large minority stake.

Now based in Coral Gables, Fla., Stiefel was founded in Germany as a maker of medicated soap. It has annual sales of roughly $1 billion and 4,000 employees and calls itself the largest independent dermatology company in the world. [MRX makes the same claim!] Other details about its financial performance aren't available.

Included in this year's pharmaceutical megadeals are Pfizer Inc.'s pending $68 billion acquisition of Wyeth and Merck & Co.'s agreement to buy Schering-Plough Corp. for $41 billion. Glaxo Chief Executive Andrew Witty has signaled a lack of interest in such blockbuster deals. But that doesn't mean the company isn't in deal-making mode.

Just last week, Glaxo struck an alliance with Pfizer to create a new company combining their HIV businesses [#msg-37066684]. That deal is expected to give Glaxo access to Pfizer's more-promising profile of AIDS drugs in development, and provide opportunities for cutting costs. Glaxo will initially own 85% of the venture, which could be valued at more than $4 billion.

Though a number of big pharmaceutical CEOs have sworn off megadeals, many of them are actively looking for smaller acquisitions. Aiding the drug companies' ability to do deals has been a friendly fund-raising environment, with bond investors eager to lend to the biggest names in the industry, which are considered defensive bets in a worsening economy. The combination of large and small deals in the works has made the drug sector a bright spot in an otherwise dismal global takeover climate.

For Blackstone, the deal would represent a positive development in a difficult market for private-equity firms, which have been constrained in their ability to sell investments by the depressed merger and IPO markets. What's more, most deals struck in 2007, at the height of the leveraged-buyout craze, are deeply under water for the private-equity firms. It's unclear how big of a profit Blackstone could make on the Stiefel deal.

Lazard Ltd. is advising Glaxo on the Stiefel deal, with Blackstone bankers advising the sellers.‹

[DewDiligence]

BSI-201 is the drug SNY recently acquired in the buyout of BiPar Sciences.

http://www.bloomberg.com/apps/news?pid=20601087&sid=a9X3jOZqvDgs

›Drugs Kill Cancer by Halting Tumor’s Ability to Heal Itself

By Tom Randall
May 31, 2009 08:30 EDT

May 31 (Bloomberg) -- An experimental cancer drug made by Sanofi-Aventis SA helped patients with advanced breast tumors live more than 60 percent longer using a new method that stops diseased cells from healing themselves, a new study found.

The treatment, called BSI-201, shrank tumors and slowed new growth in a study of 116 patients with so-called triple- negative breast cancer, an aggressive disease that doesn’t respond to many treatments. Results were presented today at the American Society of Clinical Oncology in Orlando, Florida.

BSI-201 leads an emerging class of treatments known as PARP inhibitors. Most cancer treatments work by blasting DNA with chemotherapy or radiation. Cancer can fight back by using PARP enzymes to fix damaged strands of DNA. The new medicines are designed to block the enzymes and kill the cancer.

“These PARP inhibitors are the biggest story in breast cancer, by far, and it’s going to be a huge bombshell” at the cancer conference, said Powel Brown, director of cancer prevention at the Lester and Sue Smith Breast Center at Baylor College of Medicine in Houston, Texas, in an interview before the meeting. “This mechanism is so hugely positive that this will be FDA approved within probably a year or two.”

There were no significant side effects from the BSI-201 treatment, which was added to standard chemotherapy in the research. A separate study presented at the conference showed a similar drug, called olaparib and made by London-based AstraZeneca Plc, shrank tumors even when administered without chemotherapy or radiotherapy.

Other Cancers

The tests, the second of three stages typically required for regulatory approval, focused on breast cancer. However, the PARP inhibitor method of blocking DNA repair may also work against other cancers and might reduce the amount of chemotherapy needed to treat a variety of patients, said Paul Chew, chief medical officer for Paris-based Sanofi, in an interview at the conference yesterday.

“It’s a portal to other tumors,” said Chew, who was appointed to his job in March. “This opens up a new era of cancer treatment.”

A month after Chew’s appointment, Sanofi agreed to purchase BiPar Sciences Inc. to gain BSI-201. The company will pay as much as $500 million, based on the success of the drug [#msg-37045585].

Sanofi will begin enrolling 400 patients in the next two months for an expanded trial to confirm the results. That could take as little as a year to complete before submitting to regulators for marketing approval, Chew said.

The drugmaker believes the new trial “will be sufficient” for approval, he said.

Fixing DNA

Healthy human cells have six different mechanisms to repair DNA. As cancer develops, many of those mechanisms break down, leaving the cell reliant on PARP to fix genetic damage from cancer treatments. Researchers have found that severe forms of cancer in the ovaries, uterus, lungs and pancreas all have unusually high PARP enzyme activity, meaning they could make good targets for the new therapies, according to Barry Sherman, BiPar’s chief medical officer.

In Sanofi’s study, half of patients were given BSI-201 and a combination of chemotherapies, carboplatin and Eli Lilly & Co.’s Gemzar, and half were given chemo and a placebo. About 60 percent of patients who took BSI-201 saw their tumors shrink and cancer slow, almost three times as many as those who took only chemotherapy. The median lifespan after treatment with BSI-201 was 9.2 months, compared with 5.7 months in the control group.

15 Percent of Breast Cancer

The cancer in the study is called triple negative breast cancer because it lacks the three genetic targets needed for the most effective medicines [“triple negative” means estrogen-negative, progesterone-negative, and HER2-negative]. It is responsible for about 15 percent of all breast cancers and sickens younger women more than other forms. If the cancer is detected early enough, treatment with a PARP inhibitor may be able to permanently destroy the tumors, Sherman said in an interview at the conference yesterday.

“There is an opportunity here to actually use the term ‘cure’ when it’s applied to early-stage disease,” Sherman said. “That is perhaps one of the most exciting notions to come out of this. This is the forefront of a field that is about to open up, about DNA repair.”

Abbott Laboratories and Pfizer Inc. are also investigating PARP inhibitors in early-stage human trials. Abbott’s version, called ABT-888, is being examined in 10 clinical trials to determine which treatments it works best with, said Vincent Giranda, director of PARP research at Abbott Park, Illinois- based company.

Other Disease Hints

There are “hints” that PARP inhibitors may show benefits in diseases other than cancer and may one day be used to limit damage after a heart attack or stroke, Giranda said. For now, companies are focusing on oncology, where the most dramatic results may come, he said in an interview last week.

The AstraZeneca trial focused on breast cancer patients with a mutation in a gene called BRCA, another severe disease form affecting about 5 percent of breast cancer patients. The mutation hampers other mechanisms to repair DNA, making the cancer especially reliant on PARP enzymes. The trial of 54 patients showed olaparib was safe and shrank tumors. It wasn’t designed to measure the drug’s ability to slow the disease.

“These two studies, taken together, show that PARP is a very promising drug target,” said Richard Schilsky, president of ASCO and associate dean for clinical research at University of Chicago, in an interview before the meeting. “You’re going to hear a lot more about PARP inhibitors as time goes by.”

‘Biggest Story’

Breast cancer is the second most common malignancy in women, after skin tumors, according to the Atlanta-based U.S. Centers for Disease Control and Prevention. About 187,000 women were diagnosed with breast cancer and 41,000 women died from it in 2005, the most recent year for which CDC data are available.

“The biggest story in breast cancer right now is the PARP inhibitors,” said Clifford Hudis, chief of breast cancer medicine at Memorial Sloan Kettering Cancer Center in New York, in a telephone interview last week. “Any time you open up a new target, that’s an exciting moment. These drugs may potentially be active not just to treat metastatic disease but to prevent recurrence.”‹