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Prolor CEO: It would make sense to find a partner

Prolor Biotech Inc. (AMEX: PBTH; TASE: PBTH) has enough cash to conduct late-stage studies of its longer-lasting growth hormone, CEO Dr. Shai Novik told “Bloomberg” in an interview last week, but added that it would make much more sense to find a partner. The company raised a net $35 million in a secondary offering American Stock Exchange last Wednesday.

“Can we do it on our own? Yes, Novik said. However, when you look at the marketing and sales channels, it would make much more sense, even if we develop it on our own, to partner with someone, at least for distribution and marketing purposes.”

Prolor is seeking to become the first company to market a longer-lasting growth hormone, which can be injected once a week instead of once a day. The human growth hormone market is worth $3 billion, according to “Bloomberg”. Current treatments including Genotropin, made by Pfizer Inc. (NYSE: PFE; LSE: PFZ), Humatrope, made by Eli Lilly & Co. (NYSE: LLY), and Novob, made by Denmark’s Novo Nordisk A/S (OMX: NOVO; NYSE: NVO).

Human Growth Foundation says that there are 50,000 adults in the US with growth deficiency, and that 6,000 new cases are reported each year.

Summer Street Research Partners analyst Bart Classen told “Bloomberg” that Prolors technology would be a major improvement and obviously a very attractive change for patients and physicians. Any of the companies making short-acting hormone could be interested in buying them. Theres definitely a strong chance that the company will be acquired or partner up with a number of the larger companies who would have a natural interest in this product.”

Prolor’s share price fell 1.2% by mid-afternoon on the TASE today to NIS 19.58, after falling 2.4% on the AMEX on Friday to $4.95, giving a market cap of $274 million.

Published by Globes [online], Israel business news – www.globes-online.com – on May 20, 2012

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Prolor CEO: It would make sense to find a partner

Roger Clemens former trainer sticks to his guns

IAN SIMPSON

The key witness in Roger Clemens’ perjury trial stuck to his testimony that the former baseball ace used performance-enhancing drugs even as the defence hammered him for saying he had lied to investigators.

Brian McNamee, Clemens’ former trainer, faced unrelenting cross-examination about his role in the star pitcher’s alleged use of anabolic steroids and human growth hormone.

But while admitting he had delayed handing over evidence of an alleged injection and lied about how many times he had given Clemens shots, McNamee repeatedly told jurors in US District Court that Clemens was a drug user.

“I never lied about the usage (of steroids), just the amount,” said McNamee, who will return for more cross-examination on Friday.

“I wanted to not make it look like he was a bigger steroid user than he was.”

In about 20 hours of testimony, McNamee, 45, has sworn he injected Clemens with anabolic steroids in 1998, 2000 and 2001 and with human growth hormone in 2000.

McNamee, at the core of prosecutors’ charges that Clemens lied to Congress about using performance-enhancing drugs, repeatedly answered “I don’t know” or “I’m not sure” under a grilling from defense attorney Rusty Hardin.

McNamee testified that he had kept mum on stashed medical waste from a 2001 injection even though federal agents and an independent commission headed by former Senator George Mitchell had asked him if he had evidence of Clemens’ alleged drug use.

Asked if he had lied about not having evidence, McNamee said: “Yes, sir.”

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Roger Clemens former trainer sticks to his guns

Key witness adamant Clemens used drugs, admits lying

WASHINGTON (Reuters) – The key witness in Roger Clemens's perjury trial stuck to his testimony that the former baseball ace used performance-enhancing drugs even as the defense hammered him on Thursday for saying he had lied to investigators. Brian McNamee, Clemens's former trainer, faced unrelenting cross-examination about his role in the star pitcher's alleged use of anabolic steroids and …

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Key witness adamant Clemens used drugs, admits lying

Prolor May Seek Partner to Market Growth Hormone Product

By David Wainer – 2012-05-16T22:01:32Z

Prolor Biotech Inc. (PBTH), an Israeli company developing improved versions of existing medicines, may seek a partner for its growth-hormone treatment as final trials are set to begin this year, President Shai Novik said.

The company, which yesterday raised $35 million through a share offering, has enough cash to conduct late-stage studies of the product, known as hGH-CTP, in adults with growth-hormone deficiency as well as mid-stage testing in children with the ailment, Novik said yesterday in an interview near Tel Aviv.

Can we do it on our own? Yes, Novik said. However, when you look at the marketing and sales channels, it would make much more sense, even if we develop it on our own, to partner with someone, at least for distribution and marketing purposes.

Prolor, based in Nes-Ziona, Israel, plans to tap a $3 billion human growth hormone market as it races to become the first to offer a longer-lasting version of human growth hormone that could be injected once weekly. Abnormally small children and adults with growth-hormone deficiency currently take daily injections of treatments such as Pfizer Inc. (PFE)s Genotropin, Novo Nordisk A/S (NOVOB)s Norditropin, and Eli Lilly & Co. (LLY)s Humatrope.

Prolor said on May 7 its mid-stage study of hGH-CTP in adults showed that a single injection could potentially replace seven consecutive daily injections of commercially available human growth hormone therapies.

Prolors technology would be a major improvement and obviously a very attractive change for patients and physicians, Bart Classen, an analyst at Summer Street Research Partners, said by telephone. Any of the companies making short-acting hormone could be interested in buying them. Theres definitely a strong chance that the company will be acquired or partner up with a number of the larger companies who would have a natural interest in this product.

Phillip Frost, chairman of generic-drug maker Teva Pharmaceutical Industries Ltd. (TEVA), owns about 20 percent of Prolor. Teva, which paid $6.5 billion to acquire U.S. biotechnology company Cephalon Inc. last year, needs new sources of revenue as its top-selling treatment, a branded multiple-sclerosis medicine called Copaxone, faces increased competition.

More than 50,000 adults in the U.S. are growth-deficient and 6,000 new cases are reported each year, according to the Human Growth Foundation. Side effects of hormone deficiency can include increased fat mass, diminished muscle strength, physical energy and stamina.

Prolor shares were little changed at $5.20 in New York yesterday. The companys shares have risen 22 percent this year.

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Dr. Jacqueline Gerhart: Should reader be worried about low testosterone?

Dear Dr. Gerhart: I was wondering if you would talk about “low T.” I saw a commercial about how men can have low testosterone if they feel fatigued and are gaining weight, or if their libido is low, and they should talk to a doctor. Well, that’s me. What should I do?

Dear Reader: I spend quite a bit of time as a primary care doctor talking about estrogen, progesterone and menopause. Less commonly, men ask me about their testosterone levels in response to aging.

A man’s testosterone level fluctuates during the day, with highest levels in the morning, and lowest levels in the evening. A “normal” testosterone level depends on your age, since testosterone levels naturally decline as you get older.

During puberty, a man’s testosterone levels are high, allowing for the deepening of his voice, the developing of his muscles and the transition of sexual characteristics from “boy” to “man.” After age 30, testosterone levels slowly decline, and along with that can come symptoms of fatigue, depression, weight gain, decreased muscle mass and decreased libido.

If you suspect you may have low testosterone, first think if this is normal for your age. If you are 80 years old and are noticing muscle loss, this is normal. However, if you are 30 years old or younger and have the above symptoms, be sure to see your physician.

Your physician will do a history and physical exam to determine possible other causes for your symptoms. Then he or she will likely perform blood tests to look at your hormones, electrolytes, vitamin and mineral levels, and blood count. This is to look for other reasons for fatigue, such as low thyroid hormone, low iron or low Vitamin D.

A normal total testosterone level in the blood is usually above 300 nanograms per deciliter (ng/dL). If your level is lower than this, your doctor will have you repeat the test in the morning, around 8 a.m., when testosterone levels are the highest. A second level of total testosterone less than 300 may indicate you have “low T.”

If this is the case, your physician will likely suggest lifestyle changes such as improving your diet and increasing exercise to help with the symptoms of weight gain and fatigue. Mildly low levels of testosterone often can be tolerated without medications.

Medications and treatments often are given when the testosterone level is 200 or lower. If you have low testosterone and you and your partner are trying to become pregnant, testosterone injections may be helpful. If given every few weeks, they can stimulate sperm production. If fertility is not your concern, then testosterone is usually given through a daily gel or patch.

The benefits of testosterone treatment are decreased symptoms and decreased risk of osteoporosis and bone fracture. Testosterone treatments usually are not recommended for men with prostate cancer. It also is not frequently used for men with mild testosterone deficiency or for those at a natural testosterone level for their age. When testosterone treatment is used, we usually ask an endocrinologist specialist to help with treatment and monitoring.

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Dr. Jacqueline Gerhart: Should reader be worried about low testosterone?

Clemens' ex-coach says he feared being fall guy

Brian McNamee testified Tuesday he saved medical waste after injecting Roger Clemens with steroids because his wife complained that McNamee was going to be the fall guy.

McNamee said his wife, Eileen, told him, Youre going to go down! Youre going to go down! Youre going to go down!

McNamee, Clemens former strength coach, has said he injected the seven-time Cy Young Award winner multiple times with steroids and human growth hormone. He said he had told his wife about the injections.

He said he wanted to do something that would make his wife stop giving him a hard time every single day, so he took a swab and cotton ball from a Clemens steroid injection in 2001, put it in a beer can, and brought it home.

He said when he showed it to his wife, she said, all right.

The waste collected by McNamee is the physical evidence prosecutors are using against Clemens in his perjury trial. Clemens is accused of lying to Congress in 2008 when he denied using steroids or HGH.

McNamee said he stored the material in a FedEx box, first in a closet in his basement, then in a closet in his master bedroom. He said he didnt have any plans to use the material in any way.

In his 2008 congressional deposition, McNamee said he kept the materials because he distrusted Clemens to a degree.

McNamee, who testified Monday that he injected Clemens with steroids 8 to 10 times when they were with the Toronto Blue Jays in 1998, said Tuesday he injected him on multiples occasions when the two men were reunited with the New York Yankees in 2000 and 2001.

According to McNamee, Clemens told him in 2000, Im ready to start up again. You have a guy, right? McNamee turned to Kurt Radomski, who touted human growth hormone, as the latest and greatest, and McNamee went back to check with Clemens.

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Clemens' ex-coach says he feared being fall guy

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What is HGH? | BBC Documentary Explaining Human Growth Hormone – Video

Trainer: I saved Clemens' HGH waste

(CBS/AP) WASHINGTON – Amid his year-by-year narrative of his complex relationship with Roger Clemens and performance-enhancing drugs, Brian McNamee weaved in a tale of two wives. He said it was his own wife who nagged him into keeping evidence that has become crucial in the trial of the storied pitcher, and it was a request from Clemens’ wife that led to what McNamee called a “creepy” injection scene in a bathroom.

Clemens’ longtime strength coach testified Tuesday for a second day in the perjury trial, which pushed his running total to more than nine hours on the stand, with cross-examination yet to come. The broad outline was familiar from McNamee’s previous statements: He said he injected Clemens with steroids and human growth hormone in 2000 and with steroids in 2001, and he gave Debbie Clemens a shot of HGH in 2003. That was in addition to the testimony he gave Monday, when he spoke of a series of steroids injections he said he gave Clemens in 1998, when he was pitching for the Toronto Blue Jays.

He went on to describe his marital problems, money problems and the legal mess that came about when he got entangled in the federal drugs-in-sports investigation that led him to become a reluctant but cooperating witness against one of the most successful baseball players of all time.

“It destroyed me. It killed me. … I put myself in a situation where I had to do this,” McNamee said. “I had to tell the truth.”

Some details were new and fascinating, especially hearing them spoken out loud in a courtroom with Clemens sitting a few feet away. At one dramatic point, the adversaries were actually both standing, when McNamee rose from the witness stand and identified Clemens with an outstretched left arm: “He’s right there with the brown tie.” Clemens looked straight at McNamee, stone-faced and silent.

Feds’ key witness: I gave Clemens steroids in 1998

McNamee is far and away the government’s key witness, the only person who will claim firsthand knowledge of Clemens taking performance-enhancing drugs. The former baseball great is accused of lying when he told Congress in 2008 that he had never used steroids or HGH.

McNamee again gave vivid and colorful details about injections. He appeared less nervous than he did on Monday, and his voice rose as he spoke of marital problems that he said developed in part because of his relationship with Clemens. The time away from home training Clemens meant McNamee didn’t have time to take his wife and children to water parks and other family outings, he said, and his wife was concerned that her husband would become a fall guy at Clemens’ expense.

“You’re going to go down! You’re going to go down! You’re going to go down!” Brian McNamee said his wife, Eileen, told him in the “middle of a battle royale” argument.

McNamee said he thought “she might be right,” so he kept the needle, swab and cotton ball from a steroids injection he said took place in Clemens’ New York City apartment in 2001. He said he put the items in a beer can that he salvaged from the recycling bin in Clemens’ kitchen a means of protecting the used needle from accidently stabbing himself and brought the can home. It was put in a FedEx box and kept in the house, an effort to “keep the home front nice and smooth,” McNamee said.

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Trainer: I saved Clemens' HGH waste

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