GlaxoSmithKline (GSK) has reported successful phase III trials of its new diabetes drug albiglutide, which it intends to file for regulatory approval.

The injectable drug, taken weekly, outperformed a rapid-acting insulin when used in combination with a daily insulin to manage type 2 diabetes.

Analysts predict the drug will earn GSK $250m per year by 2016 – not a potential ‘blockbuster’, but a robust product in the diabetes market.

Albiglutide – awaiting a new brand name after GSK dropped the name Syncria – is the latest product in the class of glucagon-like peptide-1 (GLP-1) diabetes drugs that includes Victoza from Novo Nordisk and Byetta from Amylin and Lilly.

GLP-1 drugs stimulate insulin release when glucose levels are high, a flexible property that makes them a potential alternative to insulin in patients with severe type 2 diabetes.

They have the further advantage of stimulating weight loss, which is of clinical value to most people with type 2 diabetes.

The first phase III trial of albiglutide, reported in November 2011, found it to be less effective than daily Victoza in reducing blood glucose levels – a disappointing result for GSK.

However, armed with top-line results from seven of eight phase III studies, GSK said that the cumulative data support an application for the drug’s approval as a treatment for type 2 diabetes.

One trial tested albiglutide against Lilly’s rapid-acting insulin Humalog when used in combination with Sanofi’s daily insulin Lantus.

The patients taking albiglutide experienced a 0.82 reduction in HbA1c, compared to 0.66 in the Humalog group. In addition, The albiglutide patients also lost an average of 0.73 kg in weight, whereas the Humalog patients gained 0.81 kg.

GSK expects to have all the data it needs to apply for regulatory approval by the end of 2012.

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.

The European Commission’s approval of Amylin’s diabetes drug Bydureon is expected to create jobs at its US manufacturing facility on Trade Port Drive, West Chester.

The once-a-week type II diabetes drug gained its first approval anywhere in the world last month and is expected to enter the UK and German markets by October.

Alice Izzo, an Amylin spokeswoman, says the demand for the product will determine how many new roles are created at the manufacturing facility.

The facility is the only manufacturing plant that the pharma company owns and will now switch from producing drugs made for clinical trials to those entering the market. Currently 300 employees work at the Trade Port Drive plant.

“It’s the first approval anywhere around the world, so it’s great progress for us and the facility in West Chester,” said the Amylin spokeswoman.

Bydureon is a once-weekly version of its twice-daily formulation Byetta, its biggest selling drug that lowers blood sugar. It is pending approval from the FDA, after two requests were made for further data on the safety of the drug last year. An application was also submitted recently in Japan.