So what's the verdict?

Anonymous

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I heard final bids were due last Friday. Anyone know what's going on and how much the bids came in for? I read an article (below) last week about the sales process falling.



The Daily Deal
Graceway Pharmaceuticals auction sputters
by Thomas ZAdvydas
Updated 02:01 PM, Jul-12-2011 ET
The running auction of Graceway Pharmaceuticals LLC may be on the verge of collapse because of a rival's superior drug, according to a source familiar with the situation.

Bristol, Tenn.-based Graceway, a private equity-backed pharmaceutical company that specializes in drugs used for skin treatment, earlier this year tapped Lazard for an auction after its lead drug, Aldara, went generic. The business has been pushing to get its next best hope, a drug called Zyclara used to treat skin conditions, to market.

Now, Graceway competitor Leo Pharma Inc. has its own compound, PEP005, close to government approval, and it looks to be more effective than Zyclara, according to the source. Thus, bidders involved in the Graceway auction now see the company as a less-promising target.

First-round bids for the target have come in at between $200 million and $250 million, but more recent offers have been closer to $100 million, according to a post July 5 on biotechnology trade website Cafe Pharma. The source said strategic acquirers have participated in the auction but declined to elaborate.

Graceway was formed with $200 million in backing from Chicago private equity firm GTCR Golder Rauner LLC in February 2006. It tapped former King Pharmaceuticals Inc. chief executive Jefferson Gregory to run the business and made a significant bolt-on when it bought the U.S., Canadian, and Latin American pharmaceutical operations of St. Paul, Minn.-based 3M Co. for $875 million in November that year.

Graceway and a GTCR spokesman didn't return calls. Lazard declined to comment.

The source said Graceway ran into problems after its lead skin cancer and wart treatment drug, Aldara, lost its patent exclusivity and generic versions of the compound became available on Feb. 25, 2010. The drug was generating more than $300 million in sales annually, about 80% of Graceway's total revenue.

"It went generic earlier than they were expecting, and so that basically just crushed the company," said the source, who added that Graceway is carrying more than $1 billion in debt.

In September 2010, Standard & Poor's Rating Services lowered Graceway's corporate credit rating to 'SD' from 'B-' after the business failed to make an Aug. 31, 2010, interest payment on a $330 million second-lien term loan.

A later note from S&P issued on April 29 said that the company will have serious liquidity pressures in September when a $30 million first-lien amortization payment comes due. "They're hardly doing any Ebitda right now, it became very clear that the debt needed to be restructured and maybe sold," the source said.

Graceway brought in Lazard as of at least April to help look at its options. GTCR remains the sole sponsor of the business.

Meanwhile, Graceway began to make a harder marketing push for Zyclara while the review was under way.

Trouble for Graceway's auction began about a month ago, when Leo Pharma released Phase 3 clinical trial results for its PEP005 compound, a chemical ingenol mebutate, at the World Congress of Dermatology in Seoul on June 6.

Zyclara and PEP005 are used to treat the same condition, actinic keratosis, which are precancerous skin lesions caused by sun exposure. The two compounds have similar safety and efficacy profiles, but PEP005 has a much shorter treatment cycle, according to data released by the conference. Patients typically use Zyclara for about six weeks, while the PEP005 treatment period is projected to be about two days. Leo Pharma's compound should be approved by the Food and Drug Administration later this year or early next year. When approved, PEP will be the new gold standard for actinic keratosis treatment, according to a statement by Mark Lebwohl, the lead medical investigator for PEP005. Lebwohl wouldn't comment for this story.

"It doesn't take a genius to figure out that this is going to take the vast majority of the [actinic keratosis] market," the source said.
 












How in the hell can they still have over $1 billion in debt? The company had over $ 1.2 billion on sales from 2007 to 2009. They ever had some good months in 2010. Wnat do JG, JB and BS do with all of the money? Did nothing go to service the debt?

Heck - the NASCAR sponsorship was only $ 2 million - so that can't be where they spent it.

In short, management seems to have borrowed and spent a lot of money - and have nothing to show for it today. Except a lot of ex-employees...
 












I heard final bids were due last Friday. Anyone know what's going on and how much the bids came in for? I read an article (below) last week about the sales process falling.



The Daily Deal
Graceway Pharmaceuticals auction sputters
by Thomas ZAdvydas
Updated 02:01 PM, Jul-12-2011 ET
The running auction of Graceway Pharmaceuticals LLC may be on the verge of collapse because of a rival's superior drug, according to a source familiar with the situation.

Bristol, Tenn.-based Graceway, a private equity-backed pharmaceutical company that specializes in drugs used for skin treatment, earlier this year tapped Lazard for an auction after its lead drug, Aldara, went generic. The business has been pushing to get its next best hope, a drug called Zyclara used to treat skin conditions, to market.

Now, Graceway competitor Leo Pharma Inc. has its own compound, PEP005, close to government approval, and it looks to be more effective than Zyclara, according to the source. Thus, bidders involved in the Graceway auction now see the company as a less-promising target.

First-round bids for the target have come in at between $200 million and $250 million, but more recent offers have been closer to $100 million, according to a post July 5 on biotechnology trade website Cafe Pharma. The source said strategic acquirers have participated in the auction but declined to elaborate.

Graceway was formed with $200 million in backing from Chicago private equity firm GTCR Golder Rauner LLC in February 2006. It tapped former King Pharmaceuticals Inc. chief executive Jefferson Gregory to run the business and made a significant bolt-on when it bought the U.S., Canadian, and Latin American pharmaceutical operations of St. Paul, Minn.-based 3M Co. for $875 million in November that year.

Graceway and a GTCR spokesman didn't return calls. Lazard declined to comment.

The source said Graceway ran into problems after its lead skin cancer and wart treatment drug, Aldara, lost its patent exclusivity and generic versions of the compound became available on Feb. 25, 2010. The drug was generating more than $300 million in sales annually, about 80% of Graceway's total revenue.

"It went generic earlier than they were expecting, and so that basically just crushed the company," said the source, who added that Graceway is carrying more than $1 billion in debt.

In September 2010, Standard & Poor's Rating Services lowered Graceway's corporate credit rating to 'SD' from 'B-' after the business failed to make an Aug. 31, 2010, interest payment on a $330 million second-lien term loan.

A later note from S&P issued on April 29 said that the company will have serious liquidity pressures in September when a $30 million first-lien amortization payment comes due. "They're hardly doing any Ebitda right now, it became very clear that the debt needed to be restructured and maybe sold," the source said.

Graceway brought in Lazard as of at least April to help look at its options. GTCR remains the sole sponsor of the business.

Meanwhile, Graceway began to make a harder marketing push for Zyclara while the review was under way.

Trouble for Graceway's auction began about a month ago, when Leo Pharma released Phase 3 clinical trial results for its PEP005 compound, a chemical ingenol mebutate, at the World Congress of Dermatology in Seoul on June 6.

Zyclara and PEP005 are used to treat the same condition, actinic keratosis, which are precancerous skin lesions caused by sun exposure. The two compounds have similar safety and efficacy profiles, but PEP005 has a much shorter treatment cycle, according to data released by the conference. Patients typically use Zyclara for about six weeks, while the PEP005 treatment period is projected to be about two days. Leo Pharma's compound should be approved by the Food and Drug Administration later this year or early next year. When approved, PEP will be the new gold standard for actinic keratosis treatment, according to a statement by Mark Lebwohl, the lead medical investigator for PEP005. Lebwohl wouldn't comment for this story.

"It doesn't take a genius to figure out that this is going to take the vast majority of the [actinic keratosis] market," the source said.

There is no credibility that can be given to this article, especially when the idiot claims Cafe Pharma to be a biotech trade publication. Crawl back under your rock Mr. ZAdvydas.
 












WE'RE SAVED!!!! WE'RE SAVED!!! ALDARA REALLY REALLY LIGHT IS FINALLY APPROVED, PEP WHAT??


FDA Approves Zyclara® (imiquimod) Cream, 2.5%
Posted on 07/19/2011
The Food and Drug Administration (FDA) has approved Zyclara® Cream, 2.5% for the treatment of actinic keratoses

BRISTOL, TN (July 18, 2011) - Graceway Pharmaceuticals, LLC (Graceway) announced today that the Food and Drug Administration (FDA) has approved Zyclara® Cream, 2.5% for the treatment of actinic keratoses, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses (AK). The new formulation may be used on the full face or balding scalp in a convenient 6-week dosing cycle.

“The addition of a 2.5% formulation of Zyclara Cream will provide healthcare practitioners greater flexibility when prescribing imiquimod therapy for patients with actinic keratoses,” said Dr. Darrell S. Rigel, a clinical professor of dermatology at New York University Medical Center and a former president of the American Academy of Dermatology. “The lower concentration offers greater tolerability while maintaining the efficacy that has long been associated with imiquimod.”

The clinical studies conducted with the 2.5% strength imiquimod formulation were intended to evaluate the efficacy and safety in the treatment for AK lesions on large areas of skin (greater than 25 cm2), full face or balding scalp. Of the four double-blind studies conducted to evaluate imiquimod 2.5% or 3.75% versus placebo, patients applying imiquimod 2.5% on a two weeks on, two weeks off, two weeks on dosing cycle experienced the least amount of local skin reactions from any of the treatment groups. In addition, 31percent of patients using imiquimod 2.5% cream had complete clearance of AKs versus 6 percent for the placebo group.

Local skin reactions such as erythema are consistent with treatment response. Reported severe local skin reactions with the 2.5% concentration during the two-week treatment cycle regimen were notably less than the currently available 3.75% concentration: erythema (14% versus 25%), scabbing/crusting (9% versus 14%), ulceration (9% versus 11%), and flaking/scaling/dryness (4% versus 8%).

“I am excited about the addition of the new 2.5% strength to the arsenal of tools available to treat AK. The 2.5% strength treatment regimen maintains excellent efficacy with less skin reactions than the 3.75% strength. This represents a significant new treatment for AK in patients who are primarily concerned about irritation,” said Jefferson J. Gregory, Chairman and CEO of Graceway.

It is estimated that about 10 million Americans have AK, a common pre-cancerous lesion that often develops on skin frequently exposed to the sun. AKs are considered pre-cancers and could develop into a serious form of skin cancer called squamous cell carcinoma that if left unchecked can spread to other areas of the body and organs.