AstraZeneca looks set for several agreements to boost its pipeline after suffering a host of late-stage setbacks, according to Dr Martin Mackay (pictured), Head of Research and Development.

The R&D chief indicated the pharmaceutical company is hoping to sign deals with other major pharma companies as well as targeting biotech acquisitions and licensing partnerships.

Speaking to the Financial Times, Dr Mackay said he would be “personally disappointed” if agreements to secure AZ’s future were not completed by the end of the year.

The company has been linked as one of the suitors interested in acquiring Amylin Pharmaceuticals, who reportedly rejected a hostile bid from BMS.

Shareholders at the Anglo-Swedish pharma firm have criticised the leadership of retiring CEO David Brennan for failing to securing merger and acquisition deals to compensate for its failing pipeline.

Mr Brennan announced his departure on the day AZ published their Q1 financial results which revealed an 11% drop in revenue after key brands lost patent protection.

The outgoing CEO said the pharmaceutical industry is “experiencing pressures none of which I’ve witnessed in my 36 years in the industry” but remains “very confident” AZ has the “capabilities, courage and determination to be successful into the future”.

Dr Mackay insists his research teams have remained “undistracted by recent events” at the company and said the department continue to do “the right things”.

Since he joined AZ from Pfizer in 2010, the R&D head has restructured the department, outsourcing several in-house activities whilst axing 40% of its investigational portfolio.

Shares in Amylin Pharmaceuticals doubled (54%) in price after it was revealed the company rejected a $3.5 billion takeover bid from BMS in February.

Two people with knowledge of the offer revealed that Amylin’s board rejected BMS’ $22 a share acquisition offer with analysts now predicting bids from other pharmaceutical suitors.

Robyn Karnauskas, an analyst with Deutsche Bank, says the San-Diego based company may be worth as much as $31 a share after it received regulatory approval for its diabetes drug Bydureon in January 2012.

Amylin saw its shares close at $23.77 in New York, the biggest single-day increase since August 1999.

Analysts now predict that Amylin could be set for further bids from the likes of AstraZeneca, Sanofi, Takeda and Merck.

“The question is who can extract the most value, because this is all a commercialisation story from here,” said Joshua Schimmer, an analyst from Leerink Swann.

It’s believed that BMS has not approached Amylin with a further offer since its initial bid letter, people familiar with the matter said.

Amylin is believed to be searching for a new marketing partner for its products outside the US and is in discussions with a number of interested parties, sources said, after its decade-long collaboration with Eli Lilly ended in November 2011.

It recorded $650.7 million in revenue last year, had nearly half-a-billion dollars ($496m) in long-term debts, a $924.3 million promissory note related to revenue sharing, and $204 million in cash, equivalents and short-term investments, according to a statement published around the same time as BMS’ offer.

The European Commission has granted marketing authorisation to Byetta (exenatide twice-daily) as an adjunctive therapy to basal insulin in adults with type 2 diabetes who have not achieved adequate glycaemic control.

The authorisation for adults who have not responded to metformin and/or Actos follows clinical trial data which showed Byetta helped reduced glucose levels and reduce patients’ weight.

Dr Christian Weyer, Senior Vice President, R&D, Amylin Pharmaceuticals, said the decision “provides a new option” for patients who are not “achieving treatment goals”.

Byetta, the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes, has been used by more than 1.8 million patients globally since its introduction.

In the main, double-blind, 30-week clinical trials, submitted to the EC, Byetta demonstrated a statistically significant reduction of hypoglycaemia compared to placebo. Participants who added Byetta to their insulin glargine regimen also saw their weight decrease by an average of four pounds.

“In a clinical trial, patients using fixed-dose Byetta with titrated basal insulin achieved better postprandial and overall glycaemic control, without weight gain or an increased risk of hypoglycaemia, compared to patients using titrated basal insulin without Byetta,” said Dr Weyer.

The CHMP has issued a positive opinion for the use of Byetta (exenatide twice-daily) as an add-on therapy to basal insulin for the treatment of type 2 diabetes in adults who have not achieved adequate glycaemic control.

The treatment, to be used with or without metformin and/or Actos (pioglitazone), demonstrated in clinical trials that it can reduce glycaemic control levels.

Christian Weyer, Senior Vice President, R&D, Amylin Pharmaceuticals, says Byetta “has potential as a complementary treatment approach for several reasons”.

The double-blind, 30-week clinical trial evaluating Byetta as an add-on therapy to insulin glargine showed that patients who may have been at risk of hypoglycaemia reduced their glargine dosage by a fifth.

Then, five weeks after randomisation, all patients had insulin doses titrated to achieve target fasting glucose levels. After the full 30 weeks of treatment, Byetta demonstrated a statistically significant reduction in hypoglycaemia compared to placebo, lowering levels by 1.7% from a baseline of 8.3%.

“Byetta is given in a fixed-dose regimen,” said Christian Weyer. “Its effects contribute to improved glycaemic control after meals, complementing the control of fasting blood sugar achieved with basal insulin. And in a clinical study, patients using Byetta with insulin glargine achieved better glycaemic control, without weight gain or an increased risk of hypoglycaemia, than patients using insulin glargine without Byetta.”

The injection was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes.

In November last year, Amylin and Eli Lilly announced they had amicably terminated their decade-long collaboration on the treatment.

Eli Lilly and Amylin Pharmaceuticals have mutually terminated their decade-long diabetes partnership for exenatide.

As part of the global agreement, Amylin will gain full responsibility for the drug and make an upfront payment of $250 million, plus 15% of future global net sales to Lilly, up to the combined total of $1.2 billion.

Enrique Conterno, President of Lilly Diabetes, said: “This marks an amicable end to a very productive 10-year collaboration that will continue to benefit many people worldwide. Lilly and Amylin are proud of the important accomplishments we achieved together.”

The partnership between Amylin and Lilly provided various innovations to the diabetes market, including Byetta and Bydureon.

Byetta was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA in April 2005. It is an injectable prescription that improves glucose control in adults with type 2 diabetes mellitus, when used in conjunction with a diet and exercise programme.

Investigational Bydureon received marketing authorisation in the EU in June 2011 for type 2 diabetes, and is currently under review in the US.

Daniel M. Bradbury, President and CEO of Amylin, said: “We anticipate working with one or more partners outside the US in order to maximise the global potential of this innovative molecule and achieve greater operational flexibility and efficiency.”

The mutual agreement confirms that Amylin will resume worldwide drug development and commercialisation, starting in the US and progressing to all markets by the end of 2013.

Bydureon – the first once-weekly treatment for type 2 diabetes – has been approved for use in the EU.

Bydureon (exenatide) is indicated for use in combination with metformin, a sulfonylurea, a thiazolidinedione, metformin plus a sulfonylurea or metformin plus a thiazolidinedione.

The treatment is the result of a collaboration between Eli Lilly, Amylin Pharmaceuticals and Alkermes.

“As the global impact of diabetes continues to expand, so does the need for innovative medicines to help people living with diabetes successfully fit treatment into their lives,” said Enrique Conterno, President, Lilly Diabetes.

“Bydureon is the first and only once-weekly treatment for type 2 diabetes and has demonstrated powerful efficacy in multiple clinical trials.”

The drug is delivered using a biodegradable microsphere technology developed by Alkermes and offers a continuous release of exenatide with just one weekly dose. Bydureon follows on from Byetta (exenatide) – a twice-daily injectable form of the medicine.

Eli Lilly and Company is being sued by Amylin Pharmaceuticals for engaging in uncompetitive behaviour and violating a strategic alliance between the two companies.

Amylin has accused Lilly of breaching the terms of an agreement regarding the development and commercialisation of exenatide after Lilly partnered with Boehringer Ingelheim (BI) to develop a competing medicine.

In an official statement, Amylin says it selected Lilly as a partner to “promote development and maximise sales” of its exenatide products and is “disappointed” the matter could not be resolved amicably.

Eli Lilly responded by insisting the lawsuit is “without merit” and says it will “vigorously defend” it position.

Exenatide is currently indicated as a first line treatment for type 2 diabetes and is currently under review by the FDA.

The two companies entered into an alliance in 2002 for the worldwide commercialisation and development of exenatide, currently marketed as Byetta (exenatide) injection.

But Amylin claims that Indianapolis-based Lilly engaged in “improper, unlawful and anticompetitive behaviour” by forming a similar alliance with BI to commercialise and develop its linagliptin product – a direct competitor of exenatide-containing medications.

San Diego-based Amylin’s main aim is to prevent Lilly using its sales force from selling both competing products simultaneously, but, despite the litigation, it hopes to continue working with Lilly in the future.

“Amylin is committed to exenatide, a franchise that we believe provides important treatment options for the millions of patients around the world with type 2 diabetes,” a statement said. “Notwithstanding this litigation, we intend to continue to collaborate with Lilly in the development and commercialisation of exenatide products.”