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Palatin Technologies Inc. (PTN)

Female Sexual Dysfunction (FSD) is a multifactorial condition that has anatomical, physiological, medical, psychological and social components.

FSD includes four disorders, hypoactive sexual desire disorder, female sexual arousal disorder, sexual pain disorder and orgasmic disorder. To establish a diagnosis of FSD, these syndromes must be associated with personal distress, as determined by the affected women.

Research suggests that the majority of women experience sexual dysfunction at some point in their lives, and for many it is an ongoing or recurring issue.

FSD impacts on women’s sexual functioning and on their overall sense of wellbeing. It is associated with depression and relationship satisfaction. Although it is not clear whether FSD causes depression and relationship satisfaction or vice versa, it is likely that, at least in some cases, FSD leads to depression and dissatisfaction with relationships.

Approximately 40 million American women are affected by FSD. The National Health and Social Life Survey, a probability sample study of sexual behavior in a demographically representative cohort of United States adults ages 18 to 59, found that approximately 43% of women suffer from some form of FSD.

There are no Food and Drug Administration approved drugs for FSD.

PTN reported that it has entered into a collaboration and license agreement with Gedeon Richter Plc. to co-develop and commercialize bremelanotide for female sexual dysfunction (FSD) indications in the European Union, other European countries and additional selected countries.

Under the terms of the agreement, PTN will receive total upfront payments of €7.5 million ($9.9 million). PTN and Richter will each contribute to the European co-development activities (primarily one phase 3 clinical trial in Europe) for obtaining regulatory approval in Europe. PTN anticipates that its part of the European co-development activities will be cash neutral through the European regulatory filing stage. All sales, marketing, and commercial activities and associated costs in the licensed territory will be the sole responsibility of Richter.

PTN will additionally receive €2.5 million ($3.3 million) upon initiation of its phase 3 clinical trial program in the United States. PTN is also eligible to receive €20 million ($26.4 million) regulatory related milestones. PTN has the potential to receive up to €60 million ($79.2 million) potential sales related milestones and low double-digit royalties on net sales in the licensed territory.

PTN is developing bremelanotide subcutaneous for the treatment of FSD in premenopausal women diagnosed with FSD. Bremelanotide, which is a melanocortin agonist (a compound which binds to a cell receptor and triggers a response) drug candidate, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone).

PTN is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential.

More about Palatin Technologies Inc. (PTN) at www.palatin.com

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GlaxoSmithKline plc (GSK)

The National Institutes of Health, a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency—making important discoveries that improve health and save lives. It is the largest source of funding for medical research in the world and is made up of 27 Institutes and Centers, each with a specific research agenda, often focusing on particular diseases or body systems.

Initial human testing of an investigational vaccine to prevent Ebola virus disease will begin soon by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The early-stage trial will begin initial human testing of a vaccine co-developed by NIAID and GSK and will evaluate the experimental vaccine’s safety and ability to generate an immune system response in healthy adults.

NIAID Director said that the experimental vaccine performed extremely well in protecting nonhuman primates from Ebola infection

Ebola virus disease, formerly known as Ebola haemorrhagic fever, is a severe, often fatal illness in humans, characterized by the sudden onset of fever, intense weakness, muscle pain, headache and sore throat. This is followed by vomiting, diarrhoea, rash, impaired kidney and liver function, and in some cases, both internal and external bleeding. Laboratory findings include low white blood cell and platelet counts and elevated liver enzymes.

Ebola is introduced into the human population through close contact with the blood, secretions, organs or other bodily fluids of infected animals. Ebola then spreads in the community through human-to-human transmission, with infection resulting from direct contact (through broken skin or mucous membranes) with the blood, secretions, organs or other bodily fluids of infected people, and indirect contact with environments contaminated with such fluids.

According to the World Health Organization, the 2014 Ebola outbreak is now the largest outbreak in history, with current estimates of 2,473 infections and 1350 deaths since it began in late December 2013.

Initial safety and immunogenicity data from the Phase 1 trials of the NIAID/GSK investigational Ebola vaccine are expected in late 2014.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

More about GlaxoSmithKline plc (GSK) at www.gsk.com.

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