The product will be used in patients with moderate-to-very-severe vasomotor symptoms (hot flashes/hot flushes).

The randomised, double-blind, placebo and active-controlled study will assess the safety, tolerability, and efficacy of the candidate drug.

It is estimated that 300 patients will be enrolled in the study.

Today's announcement did not trigger a milestone payment to Karo Bio from Merck.

Karo Bio has the rights to certain milestone payments from Merck, based upon the further successful clinical development of the product and its final approval. The Swedish company also has the rights to royalties on future drug sales, while Merck has the exclusive worldwide rights to all compounds, identified during the partnership. In addition, Merck is responsible for further preclinical and clinical development of the candidate drugs.

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PROLOR is using the exact same CTP peptide to extend the duration of action of otherprotein therapeutics, including human growth hormone (hGH-CTP) and interferon beta,with the aim of reducing the number of injections required for these chronicindications. Human growth hormone, which is used to treat growth hormone deficiencyin children and adults, must currently be injected between three and seven times perweek, while interferon beta, which is prescribed for the treatment of multiplesclerosis, must currently be injected between one and three times per week. Theseare both major drugs, with existing estimated market sizes of $2.7 billion for humangrowth hormone and $4.8 billion for inteferon beta, yet neither is commerciallyavailable in a long-acting version.

PROLOR is conducting a Phase I clinical trial of hGH-CTP and its CTP version ofinteferon beta is in late preclinical development. Based on data from studies inrelevant animal models, PROLOR researchers project an administration regimen forhHG-CTP ranging from one weekly to two monthly injections, compared with dailyinjections of commercial hGH required by many patients today, and an administrationregimen for its beta interferon of one injection every two to four weeks, comparedwith the one to three injections per week required for patients currently usingcommercial interferon beta.

hGH-CTP is currently in a Phase I clinical trial assessing its efficacy and safetyprofile. The trial is expected to be completed in early 2010.

"The positive opinion by the CHMP for marketing approval in Europe of Merck's CTPversion of the fertility drug FSH is a major milestone that serves to validate theutility of our CTP technology platform for the development of superior long-actingprotein therapeutics," said Dr. Avri Havron, CEO of PROLOR Biotech. "We areoptimistic that ELONVA's clinical and regulatory successes will be replicated in theongoing clinical development of our CTP-enhanced human growth hormone and betainterferon." (C) 2009 Al Bawaba (www.albawaba.com)

Over time, the website will be enriched with new tools and additional languages. The website is currently available in English and accessible via: http://www.pku.com/en. French, German, Italian and Spanish versions are expected to be available by the end of 2009, while versions in other languages are planned for 2010.

PKU is an inherited disorder whereby the body fails to break down an essential amino acid called Phenylalanine (Phe), which can be found in protein-rich food. In patients suffering from PKU, a long lasting excess level of Phe in the blood may lead to irreversible neurological disorders in children, and cognitive deficits and psychiatric disorders in adults. At present, the management of PKU consists of lifelong dietary restrictions limiting the Phe intake, often combined with food supplements or substitutes. Used with a restricted Phe diet, Kuvan(R) has been shown to help control blood levels of Phe in patients suffering from PKU.

About phenylketonuria (PKU)

PKU, a genetic disorder affecting approximately 50,000 diagnosed patients in the developed world, is caused by a deficiency of the enzyme phenylalanine hydroxylase (PAH). PAH is required for the metabolism of phenylalanine (Phe), an essential amino acid found in all protein-containing foods. If the active enzyme is not present in sufficient quantities, Phe accumulates to abnormally high levels in the blood and brain, resulting in a variety of complications including severe mental retardation and brain damage, mental illness, seizures and tremors, and cognitive problems. As a result of global newborn screening efforts implemented in the 1960s and early 1970s, virtually all PKU patients in developed countries are diagnosed at birth.

About Kuvan(R)

Developed by Merck Serono and BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN), Kuvan (sapropterin dihydrochloride), is an oral therapeutic and the first treatment indicated in Europe for the treatment of hyperphenylalaninemia (HPA) due to phenylketonuria (PKU) in patients over the age of 4; or due to tetrahydrobiopterin (BH4) deficiency. Kuvan is the synthetic form of 6R-BH4, a naturally occurring enzyme cofactor that works in conjunction with the enzyme phenylalanine hydroxylase (PAH) to metabolize phenylalanine (Phe). Clinical data show that Kuvan produces significant reductions in blood Phe levels in the subset of patients who are BH4-responsive.

Most common side effects reported with the use of Kuvan include headache, runny nose, diarrhea, vomiting, sore throat, cough, abdominal pain, stuffy nose and low levels of phenylalanine in the blood.

Kuvan is approved in 32 countries, including member states of the European Union and the USA. Under the terms of the agreement with BioMarin, Merck Serono has exclusive rights to market Kuvan in all territories outside the USA, Canada and Japan.

About Merck Serono

Merck Serono is the division for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. In the United States and Canada, EMD Serono operates through separately incorporated affiliates.

Merck Serono has leading brands serving patients with cancer (Erbitux(R), cetuximab), multiple sclerosis (Rebif(R), interferon beta-1a), infertility (Gonal-f(R), follitropin alpha), endocrine and metabolic disorders (Saizen(R) and Serostim(R), somatropin), (Kuvan(R), sapropterin dihydrochloride) as well as cardiometabolic diseases (Glucophage(R), metformin), (Concor(R), bisoprolol), (Euthyrox(R), levothyroxine). Not all products are available in all markets.

With an annual R&D expenditure of around EUR 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.6 billion in 2008, a history that began in 1668, and a future shaped by approximately 33,000 employees in 60 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit http://www.merckserono.com or http://www.merck.de

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[1] The website http://www.pku.com is already available to PKU patients and their families living in the US and is managed by BioMarin, Merck Serono's development partner.

Merck Serono, 9 Chemin des Mines, 1202 Geneva, Switzerland, Media Relations:
+41-22-414-3600

Merck's statement was in reaction to a paper published Monday in the Archives of Internal Medicine by researchers who were paid advisers to lawyers for plaintiffs in lawsuits over the pain killer, which was taken off the market in 2004.

After reviewing results from 30 clinical trials completed before Vioxx's withdrawal, the researchers concluded Vioxx raised the risk of heart-related side effects by 35 percent, said Joseph Ross, the lead author of the new study and an assistant professor of geriatrics at Mount Sinai School of Medicine.

In 2007, Merck agreed to pay $4.85 billion to settle most of the estimated 10,000 personal-injury lawsuits filed against it over Vioxx. Merck has yet to resolve a lawsuit by shareholders, The Wall Street Journal reported Tuesday.

www.upi.com