MSD’s Vaccine, ROTATEQ®, Reduced Severe Rotavirus Gastroenteritis in Infants in Asia and Africa

August 6, 2010

MSD’s Vaccine, ROTATEQ®, Reduced Severe Rotavirus Gastroenteritis in Infants in Asia and Africa

2010-08-06 01:23:02 –

In a study published today in The Lancet, ROTATEQ® (rotavirus vaccine, live, oral, pentavalent), MSD’s rotavirus vaccine, reduced the number of cases of severe rotavirus gastroenteritis by nearly half (48 percent) in infants evaluated in developing countries in Asia (Bangladesh and Vietnam) and by 39 percent in infants evaluated in developing countries in Africa (Ghana, Kenya, and Mali) through nearly two years of follow-up. This is the first study demonstrating efficacy for any rotavirus vaccine in developing countries in Asia and the first study to show efficacy for ROTATEQ in developing countries of Asia and Africa.

“We are encouraged by the data,” said study investigator Dr. Khalequz Zaman, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh. “In this study, ROTATEQ prevented severe rotavirus gastroenteritis in infants in regions in Africa and Asia where the disease burden is quite high and rotavirus vaccines are needed the most.”

ROTATEQ is an oral pentavalent vaccine indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, G4, and G-serotypes that contain P1A[8] (e.g., G9). ROTATEQ may be administered as early as 6 weeks of age. The first dose should be administered at 6 to 12 weeks of age, with the subsequent doses administered at a minimum interval of four weeks between each dose.

ROTATEQ should not be administered to infants with a demonstrated history of hypersensitivity to any component of the vaccine. Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive ROTATEQ. Cases of gastroenteritis associated with vaccine virus have been reported post-marketing in infants with SCID.

Rotavirus gastroenteritis is the leading cause of diarrheal disease mortality among children under 5 years of age, resulting in an estimated 527,000 deaths per year globally, mostly in Asia and Africa. It is highly prevalent and highly contagious, infecting nearly all children by age 5, often more than once in both developed and developing countries.

“Given the impact of rotavirus gastroenteritis in the developing world, reduction in severe rotavirus disease represents a critically important public health goal,” said Mark Feinberg, M.D., Ph.D., vice president, Medical Affairs and Policy, Merck Vaccines. “Merck is committed to advancing global health by improving access to ROTATEQ in areas most affected by the severe consequences of rotavirus disease.”

In 2009, the World Health Organization’s (WHO) Strategic Advisory Group of Experts recommended to expand rotavirus vaccine use to all regions of the world. The efficacy data for ROTATEQ in Asia and Africa, along with effectiveness data in Nicaragua, helped inform the WHO’s recommendation for expansion of the rotavirus vaccine to all regions. This recommendation led to global WHO-pre-qualification of ROTATEQ, accelerating the availability of vaccines in the developing world.

About the Study

More than 7,500 infants between 4 and 12 weeks of age from five developing countries in Asia (Bangladesh and Vietnam) and Africa (Ghana, Kenya, and Mali) were enrolled in the two-year randomized, double-blind, placebo-controlled clinical trial. The trial was designed to evaluate the efficacy of three doses of ROTATEQ (n=3,751) against severe rotavirus gastroenteritis versus placebo (n=3,753) in low income countries with high incidence of diarrheal disease mortality.

The study was coordinated through a partnership between Merck and the Rotavirus Vaccine Program (RVP), a collaboration between PATH, an international non-profit organization, WHO and the U.S. Centers for Disease Control and Prevention. Clinical trial investigators in Asia and Africa partnered with Merck and RVP to conduct the trial. The Merck and RVP partnership was initiated by the GAVI Alliance in an effort to introduce rotavirus vaccine in the developing world. The study was funded by RVP with a grant from the GAVI Alliance and was co-sponsored by Merck.

In this study, infants received ROTATEQ or placebo at approximately 6, 10, and 14 weeks of age with routine infant vaccines. Infants between 4 and 12 weeks of age who were free of symptoms of active gastrointestinal disease and could be adequately followed for safety were eligible. The primary endpoint was rotavirus gastroenteritis, irrespective of serotype, occurring 14 days or more after the third dose of ROTATEQ or placebo until the end of the study. Gastroenteritis was defined as three or more watery or looser than normal stools within a 24 hour period or forceful vomiting. Severity of rotavirus gastroenteritis was defined by a 20 point clinical scoring system (modified Vesikari system), with those cases with a score of 11 or more being classified as severe.

In Asia, 1,018 infants were randomly assigned to receive ROTATEQ and 1,018 infants received placebo; median follow-up time in both groups, from 14 days after the third dose of vaccine or placebo until final disposition, was 498 days. Over the entire study period, there were 38 cases of severe rotavirus gastroenteritis in the vaccine group, compared with 71 cases reported in the placebo group, resulting in a vaccine efficacy of 48.3 percent (95 percent CI 22.3, 66.1 percent) at sites in Asia. Through nearly two years of follow up, vaccine efficacy was 42.7 percent (95 percent CI 10.4, 63.9 percent) in Bangladesh and 63.9 percent (95 percent CI 7.6, 90.9 percent) in Vietnam.

In Africa, 2,733 infants were randomly assigned to receive ROTATEQ and 2,735 infants received placebo; median follow-up time in both groups was 527 days starting 14 days after the third dose of vaccine or placebo.
Over the entire study period, there were 79 cases of severe rotavirus gastroenteritis reported in the vaccine group, compared with the 129 cases reported in the placebo group, resulting in a vaccine efficacy of 39.3 percent (95 percent CI 19.1, 54.7 percent) at sites in Africa.

Efficacy was 55.5 percent (95 percent CI 28.0, 73.1 percent) in Ghana, 63.9 percent (95 percent CI < 0, 89.8 percent) in Kenya, and 17.6 percent (95 percent CI < 0, 45.0 percent) in Mali through nearly two years of follow up.

In post-hoc analyses, overall efficacy against severe rotavirus gastroenteritis in Asian infants was 51 percent (95 percent CI 12.8, 73.3 percent) in the first year of life and 45.5 percent (95 percent CI 1.2, 70.7 percent) in the second year of life. Efficacy in Bangladesh was 45.7 percent (95 percent CI < 0, 71.8 percent) in the first year of life and 39.3 percent (95 percent CI < 0, 69.7 percent) in the second year of life. Efficacy in Vietnam was 72.3 percent (95 percent CI < 0, 97.2 percent) in the first year of life and 64.6 percent (95 percent CI < 0, 93.9 percent) in the second year of life.

Overall efficacy against severe rotavirus gastroenteritis in African infants was 64.2 percent (95 percent CI 40.2, 79.4 percent) in the first year of life and 19.6 percent (95 percent CI < 0, 44.4 percent) in the second year of life. Efficacy in Ghana was 65.0 percent (95 percent CI 35.5, 81.9 percent) in the first year of life and 29.4 percent (95 percent CI < 0, 70.7 percent) in the second year of life. Efficacy in Kenya was 83.4 percent (95 percent CI 25.5, 98.2 percent) in the first year of life and less than 0 percent (95 percent CI < 0, 82.3 percent) in the second year of life. Efficacy in Mali was 1.0 percent (95 percent CI < 0, 81.6 percent) in the first year of life and 19.2 percent (95 percent CI < 0, 47.3 percent) in the second year of life. The surveillance system in the study protocol was designed to detect participants presenting to healthcare facilities. However, in Mali, for cultural reasons, many cases of severe diarrhea were preferentially taken to traditional healers during the first year of the study. Strengthening of the surveillance system after the first year of the study resulted in a 12-fold increase in detection of severe rotavirus gastroenteritis in Mali in the second year of life, and a higher point estimate of efficacy in the second year than in the first year. The proportion of subjects with reported serious adverse events (SAEs) was comparable between the vaccine and placebo groups in Asia (2.5 percent in ROTATEQ group, 2.0 percent in placebo group) and Africa (1.5 percent in ROTATEQ group, 1.7 percent in placebo group). The most frequent serious adverse event was pneumonia in Asia (1.2 percent in ROTATEQ group, 1.5 percent in placebo group) and gastroenteritis in Africa (0.6 percent in either ROTATEQ or placebo group). One confirmed case of intussusception (in Vietnam), in the placebo group (at Day 97 post-Dose 3), was reported during the clinical trial. “This study provided insights into how vaccine immune responses and efficacy varied in developing countries,” said Max Ciarlet, Ph.D., associate director, Merck Research Laboratories. “Several factors may adversely affect immune response and efficacy of vaccines in these regions, including poor nutrition, the presence of other intestinal bacteria and viruses, and co-infections in the digestive system.” Select Safety Information about ROTATEQ No safety or efficacy data are available from clinical trials regarding the administration of ROTATEQ to immunocompromised patients such as individuals with malignancies or who are otherwise immunocompromised; individuals receiving immunosuppressive therapy; individuals infected with HIV; or individuals who received a blood transfusion or blood products, including immunoglobulins within 42 days. More than 71,000 infants were evaluated in three Phase 3, placebo-controlled clinical trials. Parents/guardians were contacted on days 7, 14, and 42 after each dose regarding intussusception and any other serious adverse events. In the Rotavirus Efficacy and Safety Trial (REST) of more than 69,000 infants, ROTATEQ did not increase the risk of intussusception relative to placebo. There were no confirmed cases of intussesception during the 42-day period after dose one and no clustering of cases among vaccine recipients at any time period after any dose. Four cases of intussusception were reported in children who had received placebo following the one-year safety follow-up period. In a subset of more than 11,000 infants in these trials, the presence of adverse events was reported for 42 days after each dose. The most commonly reported adverse experiences with ROTATEQ (frequency >1/10) include upper respiratory infection, diarrhea, vomiting, pyrexia, otitis media, irritability, and cough.

The following adverse experiences have been spontaneously reported during post-approval use of ROTATEQ: urticaria and gastroenteritis with vaccine viral shedding in infants with SCID. Because these experiences were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.

In a prospective post-marketing observational study conducted using a large medical claims database, the risks of intussusception or Kawasaki disease resulting in emergency department visits or hospitalizations during the 30 days following any dose of vaccine were analyzed among 85,150 infants receiving one or more doses of ROTATEQ.

During the 0-30 day follow-up period after vaccination, there were no statistically significant differences in the rates of intussusception or Kawasaki disease compared with the expected background rates. In addition, there was no statistically significant increased risk of these adverse events during the 0-30 day follow-up period when comparing the 17,433 person-years of follow-up among infants receiving ROTATEQ (n equals 85,150) with the 12,339 person-years of follow up among a concurrent control group of infants who received DTaP, but not ROTATEQ (n equals 62,617).

There were six confirmed cases of intussusception among infants vaccinated with ROTATEQ compared with five among the concurrent controls vaccinated with DTaP (relative risk equals 0.8, 95 percent CI 0.22-3.52). There was one chart-confirmed case of Kawasaki disease identified among infants vaccinated with ROTATEQ and one chart-confirmed case of Kawasaki disease among concurrent DTaP controls (relative risk equals 0.7, 95 percent CI 0.01-55.56). In the general safety analyses, the Safety Monitoring Committee did not identify any specific safety concerns.

ROTATEQ® is a registered trademark of Merck & Co. Inc., Whitehouse Station, N.J., USA

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CDC: SCID is Contraindication for Rotavirus Vaccine

June 10, 2010

CDC: SCID is Contraindication for Rotavirus Vaccine

By Todd Neale, Staff Writer, MedPage Today
Published: June 10, 2010

ATLANTA — Rotavirus vaccine should not be given to infants with severe combined immunodeficiency (SCID), according to new CDC guidance.

The makers of the two live rotavirus vaccines — GlaxoSmithKline Biologicals (Rotarix) and Merck (RotaTeq) — had revised their labels in line with the change in December and February, respectively, with FDA approval.

The CDC announced the addition of severe combined immunodeficiency to the list of contraindications for the vaccines in the June 11 issue of Morbidity and Mortality Weekly Report, following consultations with members of the former Rotavirus Vaccine Work Group of the Advisory Committee on Immunization Practices (ACIP) and a review of the data.

Furthermore, “consultation with an immunologist or infectious disease specialist is advised for infants with known or suspected altered immunocompetence before rotavirus vaccine is administered,” the agency said.

Merck and GlaxoSmithKline Biologicals made the labeling changes in response to eight reports of vaccine-acquired rotavirus infection in infants with severe combined immunodeficiency since the 2006 approval of RotaTeq. Seven were related to the pentavalent RotaTeq and the last was related to the monovalent Rotarix, which was approved in 2008.

Five of the cases — four in the U.S. and one in Australia — were reported in the literature and another three — two in the U.S. and one from outside the U.S. — were reported to the Vaccine Adverse Event Reporting System.

All of the infants, who were diagnosed with severe combined immunodeficiency at between 3 and 9 months of age and had received at least one dose of the vaccine before diagnosis, had diarrhea from the rotavirus infection.

In all eight cases, vaccine-acquired rotavirus infection was confirmed by reverse-transcription-polymerase chain reaction and nucleotide sequencing.

Prolonged shedding of the virus was documented in at least six cases with a duration of up to 11 months.

For infants in whom it is not contraindicated, rotavirus vaccination is recommended by ACIP in three doses at ages 2, 4, and 6 months for RotaTeq and in two doses at ages 2 and 4 months for Rotarix.

linkback url: http://www.medpagetoday.com/InfectiousDisease/Vaccines/20595


Secretary of Health and Human Services Announces Addition of SCID to National Newborn Screening Standards

May 25, 2010

Secretary of Health and Human Services Announces Addition of SCID to National Newborn Screening Standards

TOWSON, Md., May 25 /PRNewswire/ — On May 21, 2010, Kathleen Sebelius, Secretary of Health and Human Services (HHS) announced the addition of Severe Combined Immunodeficiency (SCID) — commonly known as bubble boy disease — to the core panel of 29 genetic disorders — as part of her recommendation to adopt the national Recommended Uniform Screening Panel.  The Secretary made her announcement in a letter to Dr. Rodney Howell, Chair of the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC). SCID is the first nominated condition to be added to the core panel of disorders.

SCID is a primary immunodeficiency disease.  Affected infants lack T lymphocytes, the white blood cells that help resist infections due to a wide array of viruses, bacteria and fungi.  Babies with SCID appear healthy at birth, but without early treatment, most often by bone marrow transplant from a healthy donor, these infants cannot survive.

The Immune Deficiency Foundation (IDF), the national patient organization for persons with primary immunodeficiency diseases, applauds the action by Secretary Sebelius for including SCID in the new national standards.  “The addition of SCID to the national newborn screening standards is a momentous step forward for the primary immunodeficiency community,” said Marcia Boyle, President & Founder of IDF.  “The IDF has strongly supported and worked tirelessly toward this goal for years.  It is imperative that we sustain this momentum by establishing newborn screening programs in all 50 states.”

“Although this recommendation has been in development for two years,” said Dr. Amy Brower, parent, researcher and former SACHDNC committee member, “it may take several more years to implement screening in all 50 states and US territories.  We must work to quickly implement the widespread adoption of testing and treatment in all of the states.”

“As the parent of a child who was diagnosed with SCID only after he became critically ill,” said Barb Ballard, a member of the IDF Board of Trustees, “I am immensely pleased with the action taken by Secretary Sebelius.”

“Our goal is to have Newborn Screening for SCID passed in all 50 states,” said Heather Smith, co-founder of SCID Angels for Life, who lost her six-month-old son, Brandon, to this devastating disease.

For more information, please contact IDF at 800-296-4433, or idf@primaryimmune.org.  Or visit the IDF website at www.primaryimmune.org.

SOURCE Immune Deficiency Foundation

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Committee Outlines Procedures for Making Newborn Screening Recommendations

March 23, 2010

Committee Outlines Procedures for Making Newborn Screening Recommendations

Evaluation of Evidence Must Account for Scarce Data on Rare Diseases

Philadelphia, PA. (March 23, 2010) –The experts who make recommendations for genetic disease screening in newborns face a challenging task: To make conclusions based on the most authoritative available evidence, while considering gaps in the research on such rare conditions, as well as their human impact. An overview of the steps followed by the expert panels tasked with making these recommendations is presented in a special section of the April issue of Genetics in Medicine (www.geneticsinmedicine.org), the official peer-reviewed journal of The American College of Medical Genetics (ACMG). The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, and pharmacy.

The articles seek to communicate a review process that includes “careful assessment of the evidence, elimination of conflicts of interest, and transparency with significant public input throughout,” according to an introductory comment by Alan R. Fleischman, M.D., and Jennifer L. Howse, Ph.D., of the March of Dimes Foundation.

Effort Emphasizes ‘Unique Role of Unique Evidence’
The Secretary’s Advisory Committee on Heritable Disorders in Newborns in Children was chartered in 2003 to make recommendations to the Secretary of Health and Human Services regarding which genetic diseases should be included in newborn screening programs. A 2006 ACMG report recommended mandatory newborn screening for a core panel of 29 conditions, most of which are currently included in the newborn screening program of every state.

“The ACMG report was enthusiastically endorsed by the Secretary’s Advisory Committee as well as the American Academy of Pediatrics, the March of Dimes and other organizations,” Dr. Fleischman and Howse write. However, some commentators have questioned the methods used in making these recommendations, suggesting that the process “does not conform to contemporary standards of evidence-based decision making.”

To address these concerns, members of the Secretary’s Advisory Committee outline the process followed in making its recommendations. A key issue is the relative scarcity of data concerning most genetic diseases in infants, many of which are very rare. The threshold for evidence is “inherently different” than that for screening of more common conditions, such as cancer or cardiovascular disease.

The multi-step process includes assessment of the availability and quality of research evidence, the accuracy of the available screening tests, and the potential benefits of early detection and treatment. These are similar to the issues involved in screening for more common diseases. However, the process includes “more flexible criteria…to accommodate the data limitations stemming from the rarity of many of these conditions,” according to the Secretary’s Advisory Committee report.

In addition to considering published scientific evidence, the Committee seeks involvement of parent/advocacy groups, as well as experts who may have specialized knowledge in this rapidly-evolving field. In outlining the process and including the input of advocates and experts, the Committee has sought to develop “consistent and transparent strategies for evidence review.”

The special issue also presents updates on the prospects for new tests for specific genetic diseases, some of which may soon be evaluated by the Secretary’s Advisory Committee:

  • A new and improved diagnostic test for fragile X syndrome-the most common inherited cause of mental impairment-which may soon make it practical to perform newborn screening and carrier testing for fragile X mutations.
  • Progress in diagnostic testing for spinal muscular atrophy, a neurodegenerative disease that is the most common genetic cause of death in infants. Last year, the ACMG formally recommended population carrier screening for this condition.
  • An update on testing for the 22q11 deletion syndrome: A highly variable condition that causes few problems in some children, learning disabilities or autism in others, and heart defects and seizures in others. Although no test is available yet, decisions about this condition are likely to set a precedent for the addition of other chromosomal diseases.
  • Connexin-26-associated deafness, a common form of inherited hearing loss that worsens over time in many children.

Note to editors: Interviews with the lead authors available upon request by contacting Kathy Beal, Public Relations Director for the ACMG: phone 301-238-4582 or e-mail kbeal@acmg.net. A separate press release has been issued providing more detailed coverage of the new test for fragile X syndrome.

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Rotavirus vaccine effective in reducing pediatric deaths, illness in developing nations

January 28, 2010

Rotavirus vaccine effective in reducing pediatric deaths, illness in developing nations

Rotavirus vaccine use likely contributed to a reduction in pediatric deaths in Mexico and a reduction in severe gastroenteritis in vaccinated African infants, according to two studies published today in The New England Journal of Medicine. However, a brief report in the same journal also cautions against use of rotavirus vaccines in children with severe combined immunodeficiency.

Researchers from the National Center for Child and Adolescent Health, Ministry of Health, Mexico City and the CDC said that a rotavirus vaccination program introduced in Mexico in February 2006 led to a marked reduction in deaths from diarrhea among young children.

The researchers compared annual deaths from diarrhea before and after the immunization program began. The researchers noted that for the three years before the vaccination program began, the median annual number of diarrhea-related deaths among children younger than 5 was 1,793, for a mortality rate of 18.1 deaths per 100,000. That number dropped to 1,118 deaths in 2008, which yielded a mortality rate of 11.8 per 100,000 children. The researchers said diarrhea-related mortality was 29% lower for children between the ages of 12 and 23 months, few of whom were age-eligible for vaccination, but mortality among unvaccinated children between the ages of 24 and 59 months did not change significantly.

The researchers noted that their study findings were limited in that it was not possible to attribute the reduction in deaths to vaccination, because precise vaccine coverage information is lacking and other changes, like improved hand hygiene, may have affected the rates.

In the second study, researchers in South Africa and Malawi enrolled 4,939 infants in clinical trials examining the efficacy of GlaxoSmithKline’s rotavirus vaccine, Rotarix.

Healthy babies were randomly assigned (1:1:1) to receive placebo followed by two or three doses of vaccine, or three doses of placebo, respectively, at 6, 10 and 14 weeks of age with routine childhood vaccines including oral poliovirus vaccine.

The researchers in that study noted rotavirus-related gastroenteritis occurred in 4.9% of the placebo group and in 1.9% of the pooled vaccine group, yielding a statistically significant vaccine efficacy of 61.2%. The researchers said efficacy against all-cause severe gastroenteritis was 30.2%.

In a brief report accompanying the two journal articles, researchers from Baylor College of Medicine noted that it is important to remember that the rotavirus vaccines can actually cause the disease in infants born with severe combined immunodeficiency.

In the report, experts examined three cases in which infants developed rotavirus disease after receiving the live attenuated rotavirus vaccine.

“All three infants (in the study) were vaccinated before they were diagnosed with severe combined immunodeficiency,” Paula Hertel, MD, assistant professor of pediatrics-gastroenterology at BCM and Texas Children’s Hospital, and study researcher said in a press release. “If the children could have been caught in a screening test done within days of birth, they may not have received the vaccine.”

While current routine newborn screening does test for many diseases, severe combined immune deficiency is not one of them, the researchers in the brief report noted.

Usually, experts recommend that children with severe combined immune deficiency not receive live vaccines. However, this vaccine must be given before most children are diagnosed with the immune disorder. The American College of Medical Genetics recently recommended that severe combined immunodeficiency be included as a part of the newborn screen.

Scientists analyzed the viral genetic material in stool specimens from the three children. This enabled them to determine that the rotavirus was of vaccine origin. This study led to a change in the vaccine exclusions listed on the vaccine manufacturer’s label to include a history of severe combined immunodeficiency.

The children did not successfully fight the infection until they underwent bone marrow transplantation or enzyme replacement therapy that gave them a functioning immune system, researchers noted.

The vaccine is very important for healthy infants, and in the United States, rotavirus cases decreased by 50% after the first season of vaccinations against the illness, said Hertel.

linkback url: http://www.pediatricsupersite.com/view.aspx?rid=60461


Enzon Stockholders Approve Sale of Specialty Pharmaceutical Business

January 27, 2010

Enzon Stockholders Approve Sale of Specialty Pharmaceutical Business

BRIDGEWATER, NJ – January 27, 2010 – Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) (“Enzon”) announced that at a special meeting held this morning, its stockholders approved the sale of Enzon’s specialty pharmaceutical business to the sigma-tau Group (“sigma-tau”).

Enzon’s specialty pharmaceutical business includes four marketed products, Oncaspar®, Adagen®, DepoCyt®, and Abelcet®, as well as a manufacturing facility in Indianapolis, Indiana.

As previously announced, Enzon has entered into a definitive agreement to sell its specialty pharmaceutical business to sigma-tau for $300 million plus an additional amount of up to $27 million based on success milestones. Enzon will also receive royalties of 5 to 10 percent on incremental net sales above a 2009 baseline amount from Enzon’s four marketed specialty pharmaceutical products through 2014.

The asset sale is expected to be completed later this week.

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Enzon sells specialty drug business for $300M

November 9, 2009

Enzon sells specialty drug business for $300M

(AP) – Nov 9, 2009

BRIDGEWATER, N.J. — Enzon Pharmaceuticals Inc. said Monday it is selling most of its business to Italian drugmaker sigma-tau Group and will focus on its experimental cancer drugs and technologies.

Enzon will get $300 million upfront, along with milestone payments of as much as $27 million. Sigma-tau could also pay Enzon royalties on Enzon’s four approved drugs through 2014. Sigma-tau is also acquiring a manufacturing facility in Indianapolis in the deal.

Enzon stock reached an annual high of $9.60 on the news. That was its highest price since December 2007.

The specialty drugs sigma-tau is buying are cancer drug Oncaspar, fungal infection treatment Abelcet, meningitis drug DepoCyt, and Adagen, which is used for severe combined immunodeficiency disease, or “Bubble Boy Disease.”

In 2008, Enzon announced plans to spin off its biotechnology business into an independent company so it could focus on developing treatments for cancer. It canceled those plans in December due to the weak state of the financial markets. With the specialty drug unit sold, the company said it will focus on potential cancer treatments including the drug candidate Peg SN38.

The transaction, which is subject to financing and approval by Enzon shareholders, is expected to close in the first quarter next year.

In morning trading, Enzon shares rose 43 cents, or 4.7 percent, to $9.41.

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