6/30/2010

Pharmalink AB Closes Deal With Grifols SA for the Acquisition of the Xepol(R) Programme for the Treatment of Post-Polio Syndrome

Pharmalink AB Closes Deal With Grifols SA for the Acquisition of the Xepol(R) Programme for the Treatment of Post-Polio Syndrome

Posted on: Wednesday, 30 June 2010, 03:51 CDT

STOCKHOLMJune 30, 2010 /PRNewswire/ --

- Agreement Marks Milestone in Pharmalink's Corporate Development

Pharmalink AB, today announced that it has closed its agreement with Grifols SA for the acquisition of Pharmalink's Xepol(R) programme for the treatment of post-polio syndrome (PPS). The parties had previously announced reaching an agreement whereby Grifols would acquire all know-how and global intellectual property rights related to the use of human immunoglobulin for the treatment of (PPS) - the concept at the heart of the Xepol programme.
The agreement covers acquisition of one of Pharmalink's wholly owned subsidiaries and includes inter alia US, EU and Japanpatents for the treatment of PPS with immunoglobulins, a US Orphan Drug Designation (ODD) for the use of immunoglobulin for the treatment of PPS and documentation of a number of clinical studies carried out in the recent years.
Johan Haggblad, Managing director of Pharmalink AB said: "This agreement marks a significant milestone in Pharmalink's corporate development. In developing a concept originally devised by academic researchers at the Karolinska Institute and seeing it through to being acquired by a world class company we have demonstrated the considerable value creation made possible by the Pharmalink model. We are very happy to see Grifols, our long standing partner, acquire and develop the PPS indication and to have played a part in bringing forward a treatment for this underserved condition."
Grifols will develop the PPS product opportunity using the acquired assets. Pharmalink will assist in technology transfer and provide contact with its network of physicians and patient organizations. The purchase price is undisclosed but divided into an up-front payment and commercial milestone payments.
The PPS product opportunity is an important means to provide a treatment to a patient group largely suffering without effective medication and to expand sales of immunoglobulin in new patient segments.
About PPS

Several decades after suffering acute polio infection survivors commonly develop PPS characterized by new or increased muscle weakness, fatigue, and pain. Ongoing denervation is the most often suggested for increased muscle weakness associated with polio infection.
Patients with PPS have increased expression of mRNA for proinflammatory cytokines in cerebrospinal fluid which suggests an inflammatory process in the central nervous system. Some patients with asymmetrical weakness have increased wear and tear on joints and muscles, including breathing muscles.
While rarely fatal, the neurological and muscular symptoms of PPS are lifelong and debilitating.
The most recent polio epidemic culminated in the Western countries around 1950. As most infections occur in children, there is nowadays a large pool of polio survivors with varying degrees of functional decline. US National Institute of Neurological Disorders and Stroke (NINDS) gives a prevalence interval for PPS of 25 to 50% (in primary polio infection survivors), WHO estimates a 40 % prevalence; assuming a prevalence of 30%, only in major Western countries there would be around 300,000 PPS patients.

Currently there is no pharmacological treatment for PPS. Several therapeutic agents have failed in achieving positive outcomes. Treatment practices are based on physiotherapy, non-fatiguing exercise and the use of assistive devices. The promising results with immunoglobulin may help address the unmet medical need of some PPS patients. In several clinical trials lead by a team of physicians at Karolinska Institutet (Sweden) and sponsored by Pharmalink AB, immunoglobulin has shown significant and clinically meaningful results in endpoints such as pain, walking ability and quality of life (SF-36 scores) by down-regulating the inflammatory process in the nervous system of PPS patients.
About Pharmalink
Pharmalink is a Swedish specialty pharma company developing high value products for niche indications. Pharmalink draws on its extensive experience of pharmaceutical product development and the excellence of medical science in Sweden to identify and progress products that address significant unmet medical needs. Pharmalink has introduced more than 15 pharmaceutical products to the market. Using a repurposing and reformulation strategy, Pharmalink minimizes the risk of product development. The Company's strategy is to develop drugs to clinical proof-of-concept and then to out-license or divest to a commercial partner. Pharmalink currently has two clinical phase development projects, Nefecon(R) and BusulipoTM, mature for out-licensing to a commercial partner and is actively in-licensing promising new projects to add to its pipeline. Visit http://www.pharmalink.se for further information.

About Grifols
Grifols is a Spanish holding company specialized in the pharmaceutical-hospital sector and is present in more than 90 countries. Since 2006, the company has been listed on the Spanish Stock Exchange ("Mercado Continuo") and is part of the Ibex-35. Currently it is the first company in the European sector in plasma derivatives and the fourth in production worldwide. In upcoming years, the company will strengthen its leadership in the industry as a vertically integrated company, thanks to recent investments. In terms of raw materials, Grifols has ensured its plasma supply with 80 plasmapheresis centers in the United States and in terms of fractionation, its plants in Barcelona (Spain) and Los Angeles (United States) will allow the company to respond to the growing market demand. Nevertheless, the company is preparing for sustained growth in the following 8-10 years and has launched an ambitious investment plan.

For further information, please contact: Pharmalink AB: Johan Haggblad, Managing Director, +46(0)70-668-0644 Email: johan.haggblad@pharmalink.se http://www.pharmalink.se Citigate Dewe Rogerson: Chris Gardner/Nina Enegren, +44-207-638-9571 Grifols SA: Raquel Lumbreras Lanchas/Borja Gomez Vazquez Tel : +34-91-311-92-89/+34-91-311-92-90 Mobile: +34-659-57-21-85 Email: raquel_lumbreras@duomocomunicacion.com borja_gomez@duomocomunicacion.com
SOURCE Pharmalink AB


Source: PR Newswire

The Polio Crusade

THE POLIO CRUSADE IN AMERICAN EXPERIENCE A GOOD VIDEO THE STORY OF THE POLIO CRUSADE pays tribute to a time when Americans banded together to conquer a terrible disease. The medical breakthrough saved countless lives and had a pervasive impact on American philanthropy that ... Continue reading..http://www.pbs.org/wgbh/americanexperience/polio/

Erradicación de La poliomielitis

Polio Tricisilla Adaptada

March Of Dimes Polio History

Dr. Bruno

video

movie

movie2

A 41-year-old man developed an acute illness at the age of 9 months during which, following a viral illness with headache, he developed severe weakness and wasting of the limbs of the left side. After several months he began to recover, such that he was able to walk at the age of 2 years and later was able to run, although he was never very good at sports. He had stable function until the age of 18 when he began to notice greater than usual difficulty lifting heavy objects. By the age of 25 he was noticing progressive difficulty walking due to weakness of both legs, and he noticed that the right calf had become larger. The symptoms became more noticeable over the course of the next 10 years and ultimately both upper as well as both lower limbs had become noticeably weaker.

On examination there was wasting of the muscles of upper and lower limbs on the left, and massively hypertrophied gastrocnemius, soleus and tensor fascia late on the right. The calf circumference on the right exceeded that on the left by 10 cm (figure1). The right shoulder girdle, triceps, thenar eminence and small muscles of the hand were wasted and there was winging of both scapulae. The right quadriceps was also wasted. The wasted muscles were also weak but the hypertrophied right ankle plantar flexors had normal power. The tendon reflexes were absent in the lower limbs and present in the upper limbs, although the right triceps was reduced. The remainder of the examination was normal.

Figure 1

The patient's legs, showing massive enlargement of the right calf and wasting on the left

Questions

1
What is that nature of the acute illness in infancy?
2
What is the nature of the subsequent deterioration?
3
What investigations should be performed?
4
What is the differential diagnosis of the cause of the progressive calf hypertrophy?

Answers

QUESTION 1

An acute paralytic illness which follows symptoms of a viral infection with or without signs of meningitis is typical of poliomyelitis. Usually caused by one of the three polio viruses, it may also occur following vaccination and following infections with other enteroviruses.1 Other disorders which would cause a similar syndrome but with upper motor neurone signs would include acute vascular lesions, meningoencephalitis and acute disseminated encephalomyelitis.

QUESTION 2

A progressive functional deterioration many years after paralytic poliomyelitis is well known, although its pathogenesis is not fully understood.2 It is a diagnosis of exclusion; a careful search for alternative causes, for example, orthopaedic deformities such as osteoarthritis or worsening scoliosis, superimposed neurological disorders such as entrapment neuropathies or coincidental muscle disease or neuropathy, and general medical causes such as respiratory complications and endocrinopathies.3

QUESTION 3

Investigations revealed normal blood count and erythrocyte sedimentation rate and normal biochemistry apart from a raised creatine kinase at 330 IU/l (normal range 60–120 IU/l), which is commonly seen in cases of ongoing denervation. Electromyography showed evidence of denervation in the right APB and FDI with polyphasic motor units and complex repetitive discharges, no spontaneous activity in the left calf and large polyphasic units in the right calf consistent with chronic partial denervation. Motor and sensory conduction velocities were normal. A lumbar myelogram was normal. Magnetic resonance imaging (MRI) scan of the calves is shown in figure2.

Figure 2

Axial T1 weighted MRI scan (TR 588 ms, TE 15 ms) of the calves, showing gross muscle atrophy and replacement by adipose tissue on the left, and hypertrophy of the muscles on the right, with only minor adipose tissue deposition

QUESTION 4

The differential diagnosis of the progressive calf hypertrophy is given in the box.

Causes of calf muscle hypertrophy

Chronic partial denervation

  • radiculopathy

  • peripheral neuropathy

  • hereditary motor and sensory neuropathy

  • spinal muscular atrophy

  • following paralytic poliomyelitis

    Neuromyotonia and myokymia

  • Isaac's syndrome

  • generalised myokymia

  • neurotonia

  • continuous muscle fibre activity due to: chronic inflammatory demyelinating polyradiculopathy, Guillain Barre syndrome, myasthenia gravis, thymoma, thyrotoxicosis, thyroiditis

    Muscular dystrophies

    Myositis

    Infiltration

  • tumours

  • amyloidosis

  • cysticercosis

    Link here