AstraZenca has ended its agreement with MAP Pharmaceuticals covering unit dose budesonide (UDB) due to the previously reported Phase III failure in pediatric asthma. Additionally, MAP Pharmaceuticals has decided to suspend development of UDB.

The agreement, which began with a $40 million up-front fee, had the potential to be worth up to $900 million.

[ad]

“MAP Pharmaceuticals is considering options for its pediatric asthma program moving forward, including the development of a next-generation therapy with budesonide,” says Timothy S. Nelson, president and CEO.

In February, the companies announced that UDB did not significantly improve asthma control in either of the doses evaluated when compared to placebo. MAP Pharmaceuticals stock plummeted 65% in the first day of trading after this news to $3.79. Since then positive results from a late-stage study of Levadex as a migraine therapy has helped pushed the share price back up, and the firm opened today at $10.44.

“MAP Pharmaceuticals remains focused on developing our Levadex migraine therapy, which recently achieved all four primary endpoints in a Phase III clinical trial,” adds Nelson.

MAP Pharmaceuticals finished the first quarter with cash and cash equivalents of $67.7 million and $4.7 million in accounts receivables.

[ad]

Besides the $40 million AstraZeneca initially paid in December 2008 when the deal was signed, it also agreed to another $35 million upon successs in Phase III. Further development and regulatory milestones could have totaled $240 million and sales-related milestones could have been up to $585 million.

Source: GEN News

Popularity: 3% [?]

In comments posted ahead of a meeting of the FDA’s Pediatric Advisory Committee, staff reviewers recommended that further studies be conducted on Abbott’s Depakote (divalproex) to investigate the potential for the product to cause developmental delays in the children of women who took the drug. In addition, they suggested in a separate memo that the warning label for Schering-Plough’s Asmanex (mometasone) should be updated to include information about allergic reactions. The committee is scheduled to meet on June 23.

[ad]

According to the FDA’s adverse event reports for Depakote, there were six cases of delayed development in children since the product’s approval in 1983. The label for Depakote, which is approved in the US as an anti-seizure medication and for other indications in adults, already contains a boxed warning that includes mention of birth defects in the children of some mothers who took the drug. The reviewers remarked that there were no reports of defects at birth in the six cases, and they explained that genetics and other factors could have played a role, especially in two of the cases which involve siblings with autism. They wrote that limitations in the reports “make it impossible to definitively conclude” the role of Abbott’s drug.

The staff suggested that “further study is needed to further elucidate the causality and degree of risk of foetal exposure to (Depakote) and subsequent developmental delay in children.” In response to the news, Abbott spokeswoman Raquel Powers said the drugmaker will “continue to participate in discussions with the FDA and its advisers to further evaluate any risks related to anti-epileptic drugs, neurodevelopment and pregnancy.”

[ad]

Regarding Asmanex, FDA reviewers stated that there were no adverse events “unique to the paediatric population” in the agency’s reports. However, they recommended an addition to the warnings section of the drug’s label to include mention of “immediate hypersensitivity events.” Prescribing information for other asthma drugs, including GlaxoSmithKline’s Advair (fluticasone and salmeterol) and AstraZeneca’s Symbicort (budesonide and formoterol), already carry this warning about allergic reactions, the staff indicated.

Source: FirstWord

Popularity: 4% [?]

Bloomberg reported Tuesday that AstraZeneca is being sued by Verus Pharmaceuticals in a US state court for over $1 billion. The lawsuit is based on the drugmaker’s termination of a deal to buy Verus’ paediatric asthma drug programmes, and AstraZeneca’s subsequent signing of a similar deal with MAP Pharmaceuticals for a competing product soon thereafter.

[ad]

Verus stated that AstraZeneca advised the company in November that due to toxicity results, development of a formulation of Pulmicort (budesonide) for children was not “practicable” and that regulatory proceedings with the FDA were “not feasible.” In December, AstraZeneca refused to let Verus exercise a repurchase option under their agreement on the basis that the deadline had passed, according to the plaintiff.

In addition, the lawsuit claims that AstraZeneca cancelled third-party contracts that had been arranged as part of the terminated deal. Verus suggests this shows that the drugmaker tried to “sabotage Verus’ chances of receiving FDA approval” on its own for the compound, and thereby gave an advantage to AstraZeneca’s venture with MAP. The lawsuit is seeking $280 million in compensatory damages and $1 billion in punitive damages.

AstraZeneca said it “denies any allegation that it acted improperly or illegally in connection with Verus.” Spokesperson Emily Denney explained that “after careful consideration and deliberation, the collaboration terminated under the express terms of the agreements, when AstraZeneca elected not to exercise its absolute contractual right to proceed with the project.”

Source: FirstWord

Popularity: 2% [?]

AstraZeneca announced Thursday that a US district court granted its request for a temporary restraining order barring Apotex from marketing a generic version of Pulmicort Respules (budesonide). The order will remain in effect until at least April 27, when the presiding judge will begin a hearing into whether Apotex’s version of the asthma medication should stay off the market until a patent infringement lawsuit involving the drug is resolved.

[ad]

Earlier this month, AstraZeneca filed a motion with the US District Court for the District of New Jersey, seeking to block Apotex’s generic product. AstraZeneca stated that patents for Pulmicort Respules continue until 2018, with paediatric exclusivity until 2019.

Source: FirstWord

Popularity: 2% [?]

AstraZeneca reported Tuesday that the company filed a motion in a US district court seeking to block Apotex from marketing a generic version of its asthma treatment Pulmicort Respules (budesonide) until a patent infringement lawsuit involving the drug is concluded. A hearing regarding the motion is scheduled for April 16.

[ad]

The lawsuit and motion follow Apotex’s indication of intent to market a generic version of the asthma therapy before the drug’s patents expire. AstraZeneca noted that patents for Pulmicort Respules expire in 2018, with paediatric exclusivity continuing until 2019.

In November, the company reached a settlement with Teva over patents on Pulmicort Respules, permitting the Israeli drugmaker to exclusively market a generic version of the product in the US beginning December 15, 2009.

Source: FirstWord

Popularity: 2% [?]

AstraZeneca reported on Monday that the FDA issued a complete response letter regarding the company’s request to expand approval for Symbicort (budesonide/formoterol) for the long-term maintenance treatment of asthma in patients between the ages of 6 years and 11 years.

[ad]

The agency determined that AstraZeneca did not provide adequate data to establish the appropriate dose or doses of the drug’s individual ingredients in this age group. AstraZeneca stated that it “is evaluating the complete response letter and will provide a response to the agency in due course.”

Commenting on the news, Matrix Corporate Capital analyst Navid Malik suggested the latest development could add to negative sentiment that arose last week when FDA staff expressed concerns about AstraZeneca’s application to expand use of Seroquel XR (quetiapine). Malik noted that the delay “won’t help” Symbicort in the US, where sales of the product have been weak, according to the analyst. Symbicort generated global sales of $2 billion last year.

Source: FirstWord

Popularity: 4% [?]

AstraZeneca and MAP Pharmaceuticals announced that the companies entered an exclusive worldwide agreement to develop and commercialize unit dose budesonide (UDB) in a deal that could be worth as much as $900 million for MAP. The formulation, which is designed to be nebulised more quickly and used at a lower dose than currently available asthma drugs, is being developed as a potential treatment for paediatric asthma.

[ad]

Under the deal’s terms, MAP will receive $40 million upfront and is eligible for another $35 million if the drug successfully achieves the primary endpoint and safety results of an ongoing Phase III study. In addition, the company may receive up to $240 million in other potential milestones. The collaboration also provides for sales performance-related milestone payments of up to $585 million, if the product is approved, as well as royalty payments.

Source: FirstWord

Popularity: 2% [?]

AstraZeneca on Tuesday announced that it agreed to settle patent infringement litigation regarding Teva’s generic version of the company’s Pulmicort Respules (budesonide) asthma treatment. As part of the agreement, Teva will be allowed to resume marketing its generic version of the product under an exclusive licence from AstraZeneca beginning December 15, 2009.

[ad]

Teva began shipping its generic product on November 19 after the company received FDA approval for its version of Pulmicort Respules, even though the companies were involved in a patent dispute over the drug. On November 20, a US court granted AstraZeneca a temporary restraining order to halt sales of the generic compound.

Under the terms of the settlement, Teva conceded that the patents in question are valid and enforceable, and that its version of the product infringed those patents. AstraZeneca noted that it will receive a “significant” royalty on sales of Teva’s medication, and that the generic drugmaker will compensate AstraZeneca an undisclosed amount for damages for having launched the product while a court case was still pending. The Israeli company will nonetheless be permitted to sell product that had already been shipped out in the US last week.

Furthermore, AstraZeneca indicated that it will terminate the partnership it had formed with Par Pharmaceuticals to distribute an authorised generic version of Pulmicort Respules in the US, in response to Teva’s action.

Popularity: 2% [?]