Shire acquires Premacure AB

ShireShire plc (LSE: SHP, NASDAQ: SHPG) has acquired Premacure AB of Uppsala, Sweden, a privately held biotechnology company developing a protein replacement therapy, currently in Phase II development, for the prevention of retinopathy of prematurity (ROP). ROP is a rare and potentially blinding eye disorder that primarily affects premature infants and is one of the most common causes of visual loss in childhood. Currently, only symptomatic treatment is available for ROP. Shire will purchase Premacure for an upfront payment and certain contingent payments based on the achievement of pre-specified development and commercial milestones. This acquisition underscores and expands Shire's commitment to bringing innovative therapies to patients with rare disorders worldwide.

During normal gestation, the developing fetus is reliant on certain growth factors from the maternal serum; full term babies can produce these growth factors on their own. In preterm infants (born before 31 weeks of gestation), the early separation from the maternal circulation results in a loss of specific growth factors, such as insulin-like growth factor 1 (IGF-1), that are believed to result in lifelong complications, including ROP.

This acquisition allows Shire HGT to enter a new therapeutic area - neonatology - while maintaining its focus on developing novel therapies for the treatment of rare diseases with high unmet medical need. With the acquisition of Premacure, Shire HGT will continue the ongoing Phase II study, the primary goal of which is to restore the IGF-1 levels in the preterm infant to those found during normal in utero development.

"ROP is a devastating eye disorder that can severely impact preterm infants for the rest of their lives," said Flemming Ornskov, MD, CEO Designate, Shire. "This investigational protein has the potential to provide a first-in-class treatment that may minimize the development and impact of complications arising from ROP. We will build on the work that Premacure has done and will apply Shire’s proven ability in developing protein replacement therapies for rare disorders to bring this much needed therapy to the market."

"The acquisition of Premacure by Shire further underscores the potential to change the long-term outlook for preterm infants with ROP and their families," said Jan Borg, founding CEO of Premacure. "We are excited that this program will become part of the innovative pipeline at Shire and believe that their experience and resources may accelerate the development of a product that seeks to prevent some of the devastating long-term consequences of ROP."

Premacure AB is a private company launched in 2006 by entrepreneurs and internationally recognized clinicians in the area of neonatology.

About ROP
Retinopathy of Prematurity (ROP) is a potentially blinding eye disorder that primarily affects premature infants weighing less than 2 pounds (about 1kg) who are born before 31 weeks of gestation (a full term pregnancy has a gestation of 38–42 weeks). The smaller a baby is at birth, the more likely that baby is to develop ROP. This disorder, which usually develops in both eyes, is one of the most common causes of visual loss in childhood and can lead to lifelong vision impairment and blindness.

In the US and EU, there are approximately 87,000 and 54,000 premature infants (born) born annually. Each year approximately 14,000–16,000 preterm infants in the US are affected by some degree of ROP. In 1,100–1,500 of these infants the ROP is severe enough to require medical treatment, and consequently 400–600 infants become legally blind.

About Insulin-Like Growth Factor 1
IGF-1 is primarily produced by the liver and supports normal childhood growth and development. Administration of IGF-1 to premature infants, as a substitute for the maternal and endogenous source, allows for the establishment of a physiological level of the hormone comparable to that present in utero. Such a treatment is believed to promote normal development and thereby prevent the development of complications of ROP.

Premacure initiated the clinical development of the preventative treatment with a formulation of recombinant human IGF-1 combined with a recombinant version of its naturally occurring binding protein, insulin-like growth factor-1 binding protein-3 (IFGBP3).

A Phase I clinical trial was conducted and results showed that the levels of IGF-1 were increased to within physiological levels and that administration of the investigational protein to preterm infants is generally well tolerated. A Phase II, safety and efficacy multi-centre clinical trial has started in Sweden and is on-going.

Shire enables people with life-altering conditions to lead better lives
Through our deep understanding of patients’ needs, we develop and provide healthcare in the areas of:

  • Behavioral Health and Gastro Intestinal conditions
  • Rare Diseases
  • Regenerative Medicine

as well as other symptomatic conditions treated by specialist physicians.

We aspire to imagine and lead the future of healthcare, creating value for patients, physicians, policymakers, payors and our shareholders.

Most Popular Now

FDA takes action against 14 companies for selling …

The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to...

Read more

Merck divests Biosimilars business to Fresenius

Merck, a leading science and technology company, has announced the divestment of its Biosimilars business to Fresenius. The decision to divest Biosimilars is aligned with...

Read more

FDA approves drug to treat ALS

The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's...

Read more

AstraZeneca marks a key milestone with the ‘toppin…

AstraZeneca marks a key milestone in its successful move to Cambridge, UK, with the 'topping out' of its new, state-of-the-art, strategic R&D centre and global corporate ...

Read more

FDA approves first treatment for a form of Batten …

The U.S. Food and Drug Administration today approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. Brineura is the first FDA-approved ...

Read more

Abbott announces CE Mark and first use of the worl…

Abbott (NYSE: ABT) today announced CE Mark and first use of the new Confirm RxTM Insertable Cardiac Monitor (ICM), the world's first smartphone compatible ICM that will h...

Read more

Italian-style coffee reduces the risk of prostate …

Add another typical component of the Italian way of life to the long list of foods characterizing one of the most healthy populations in the world. This time it's coffee...

Read more

Antibiotic doxycycline may offer hope for treatmen…

A study published in the journal Scientific Reports suggests that doxycycline, an antibiotic used for over half a century against bacterial infections, can be prescribed ...

Read more

Novartis exercises exclusive option agreement with…

Novartis announced today that it has notified Conatus Pharmaceuticals Inc., of its exercise of the option to an exclusive license for the global development and commercia...

Read more

England's Cancer Drugs Fund 'failed to deliver mea…

Analysis of the drugs that were approved for use by the NHS Cancer Drugs Fund (CDF) in England has shown that the fund was not good value for patients and society and may...

Read more

Imfinzi significantly reduces the risk of disease …

AstraZeneca and MedImmune, its global biologics research and development arm, today announced positive results for the Phase III PACIFIC trial, a randomised, double-blind...

Read more

Vitamin A deficiency is detrimental to blood stem …

Many specialized cells, such as in the skin, gut or blood, have a lifespan of only a few days. Therefore, steady replenishment of these cells is indispensable. They arise...

Read more

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]